The Journal of Emergency Medicine, Vol. -, No. -, pp. 1–9, 2013 Published by Elsevier Inc. Printed in the USA 0736-4679/$ - see front matter http://dx.doi.org/10.1016/j.jemermed.2013.05.011 Selected Topics: Prehospital Care VENTED CHEST SEALS FOR PREVENTION OF TENSION PNEUMOTHORAX IN A COMMUNICATING PNEUMOTHORAX Joseph G. Kotora Jr., LCDR, MC, USN, DO, Jose Henao, CDR, MC, USN, MD, Lanny F. Littlejohn, CDR, MC, USN, MD, and Sara Kircher, BS Department of Emergency Medicine, Naval Medical Center Portsmouth, Portsmouth, Virginia Reprint Address: Joseph G. Kotora Jr., CDR, MC, USN, DO, One Harmony Lane, Hackettstown, NJ 07840 chest seals (HyFin!, n = 8; Sentinel!, n = 8, SAM!, n = 8) was applied. Air was injected to a maximum of 50 mL/kg twice, followed by a 10% autologous blood infusion, and finally, a third 50 mL/kg air bolus. Survivors completed all three interventions, and a 15-min recovery period. Results: The introduction of 29.0 (±11.5) mL/kg of air resulted in tension physiology. All three seals effectively evacuated air and blood. Hemodynamic compromise failed to develop with a chest seal in place. Conclusions: HyFin!, SAM!, and Sentinel! vented chest seals are equally effective in evacuating blood and air in a communicating pneumothorax model. All three prevented tension pneumothorax formation after penetrating thoracic trauma. Published by Elsevier Inc. , Abstract—Background: Tension pneumothorax accounts for 3%–4% of combat casualties and 10% of civilian chest trauma. Air entering a wound via a communicating pneumothorax rather than by the trachea can result in respiratory arrest and death. In such cases, the Committee on Tactical Combat Casualty Care advocates the use of unvented chest seals to prevent respiratory compromise. Objective: A comparison of three commercially available vented chest seals was undertaken to evaluate the efficacy of tension pneumothorax prevention after seal application. Methods: A surgical thoracostomy was created and sealed by placing a shortened 10-mL syringe barrel (with plunger in place) into the wound. Tension pneumothorax was achieved via air introduction through a Cordis to a maximum volume of 50 mL/kg. A 20% drop in mean arterial pressure or a 20% increase in heart rate confirmed hemodynamic compromise. After evacuation, one of three vented , Keywords—chest seals; trauma; combat; tactical pneumothorax; thoracic INTRODUCTION Grant obtained through the Bureau of Medicine and Surgery, United States Navy. The views expressed in this article are those of the author(s) and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the United States Government. Three authors are military service members. This work was prepared as part of their official duties. Title 17 U.S.C. 105 provides that ‘‘Copyright protection under this title is not available for any work of the United States Government.’’ Title 17 U.S.C. 101 defines a United States Government work as a work prepared by a military service member or employee of the United States Government as part of that person’s official duties. Despite the advances in personal protective equipment, penetrating chest trauma remains a formidable cause of injury in tactical medicine. The Joint Theater Trauma Registry, a collective database of all coalition-force casualties from the conflicts in Iraq and Afghanistan, implicates thoracic trauma as the cause of lethal injury in 5%–7% of all patients (1,2). The leading mechanisms of lethal injury among deployed service personnel are improvised explosive devises (IEDs) and gunshot wounds from small arms fire (2). Although the blast waves from IEDs can cause significant lung injury, high-velocity fragments RECEIVED: 26 June 2012; FINAL SUBMISSION RECEIVED: 29 December 2012; ACCEPTED: 1 May 2013 1 2 can also cause devastating injury through secondary and tertiary blast injuries. This is the predominant wounding mechanism when IEDs cause chest trauma (1). Civilian tactical operators are at risk for similar kinetic mechanisms of injury. Open pneumothorax and tension pneumothorax are two of the most frequently fatal wounds seen among combat casualties. In addition, these wounds are readily treatable in the prehospital phase and are therefore two of the leading causes of preventable combat death. In one study examining the prevalence of tension pneumothorax in injured military personnel, radiographic evidence of tension pneumothorax was discovered in 198 of 978 casualties (3). Although tension pneumothorax is a clinical diagnosis that should be treated before obtaining any radiographic study, the study by McPherson et al. underscores the relatively high incidence of missed tension pneumothorax in combat casualties (3). If the size of the chest wall defect is equal to or greater than two thirds the diameter of the trachea, air will preferentially enter the chest wall during inspiration, rather than the trachea, resulting in respiratory failure and eventual cardiopulmonary arrest (4). Classical teaching regarding the management of an open pneumothorax involves placement of an occlusive dressing over the wound. This procedure has been endorsed by both civilian and military medical organizations (5). The current recommendation by the Committee on Tactical Combat Casualty Care (CoTCCC) endorses this mechanism in their most recent guidelines (6). Although there are no published data comparing the vented chest seals to three-sided occlusive dressings, some have argued against the use of three-sided occlusive dressings. The Royal College of Surgeons endorses the use of chest seals in open pneumothoraces, and agree that a three-sided occlusive dressing is ‘‘often ineffective’’ (7). Equally important, this intervention often requires frequent ‘‘burping’’ by prehospital medical personnel to relieve air accumulated and avoid development of a tension pneumothorax (5). When prehospital care providers in austere and technically difficult environments under low-light conditions are faced with multiple casualties with penetrating chest trauma, this can become an arduous task with a high likelihood of increased morbidity and mortality. In light of these concerns, vented chest seals were developed. These seals are designed to prevent inward airflow through the chest wound, while simultaneously allowing the evacuation of air from the chest through the valve during normal spontaneous respiration. Commercially available chest seals used to treat open pneumothoraces can fail due to poor adhesion to human skin (8). Adhesion can be further compromised by blood, sweat, dirt, and debris. Arnaud et al. studied this phenomenon in 2008 by comparing the Asherman and Bolin chest J. G. Kotora Jr. et al. seals for development of tension physiology after application in an open pneumothorax model. The results of their study did not reveal any evidence of tension pneumothorax after application of a vented chest seal (8). However, since this study, several chest seals have been developed and marketed to the United States (US) military and civilian tactical law enforcement agencies. To date, there has been no published data comparing the efficacy of commercially available vented chest seals against one another. The purpose of this study was to test three commercially available vented chest seals (HyFin!, SAM!, and Sentinel!) currently used by US military units for the treatment of open pneumothorax in the tactical environment. Each vented seal was assessed for its ability to prevent accumulation of air with resultant development of tension physiology after application. In addition, each seal was evaluated for its ability to adequately vent blood in the face of a hemopneumothorax. In addition to having a venting mechanism, each chest seal had to meet the criteria established by the CoTCCC. These criteria are presented in Table 1. The study end point was development of tension pneumothorax after application of the chest seal, defined by any of the following possible entities: a drop in the mean arterial pressure (MAP), a rise in heart rate, both a decrease in MAP and a rise in the heart rate, or death. Bedside ultrasound was utilized to assess the presence or absence of a pneumothorax, both before and after Table 1. Committee on Tactical Combat Casualty Care Required Criteria for Chest Seals (6) Required Criteria Approved by the US Food and Drug Administration Sterile Long shelf life Adherence required in the presence of blood, sweat, sand, and hair Must conform to Military Standard 8.10 G regarding storage Low allergic potential Self adherent 6–8 inches in dimension Oval shaped Creation of an occlusive seal Ventable through lifting of an occlusive flap on the seal with adequate resealing after lifting Puncture-resistant packaging Minimum weight and cube Maintenance of integrity when folded Lightweight and rugged Inexpensive Favorable clinical data when tested under battlefield conditions Easy application under battlefield conditions Built in tabs to facilitate removal High rate of user acceptance Configuration for use in low-light conditions US = United States. Chest Seals in Penetrating Trauma 3 Table 2. Volume of Air Required to Induce Tension Pneumothorax before Chest Seal Placement Volume of Air (mL/kg) to Induce Tension Pneumothorax Subject HyFin! Sentinel! SAM! 1 2 3 4 5 6 7 8 31.9 18.5 32.4 44.9 30.8 29.1 50.0 50.0 31.0 50.0 15.4 17.6 28.2 23.2 21.1 17.6 18.1 46.8 22.0 17.6 30.0 16.8 24.0 29.1 application of the seal, as well as after each injection of either air or blood. Our study group hypothesized that no statistically significant difference exists among the seals, with regard to prevention of tension pneumothorax or evacuation of blood after application. Skin adherence was not specifically tested in this study. METHODS This randomized, prospective, unblinded laboratory animal trial was approved by the Institutional Animal Care and Use Committee. All research was conducted in compliance with the Animal Welfare Act, and adhered to the principles stated in the Guide for the Care and Use of Laboratory Animals: Eighth Edition (9). Animals were maintained in a facility accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International. Twenty-four Yorkshire Swine (Sus scrofa) were fed a standard diet and observed for 5 days to ensure good health. Subjects were fasted the night before the procedure, with water provided ad libitum. Mean subject weights were 23.2 kg (standard deviation [SD] 3.10; range 18.6–28.2 kg) for the HyFin! chest seal group, 27.4 kg (SD 4.16; range 22.7–36.4 kg) for the SAM! chest seal group, and 28.1 kg (SD 4.06; range 22.7–36.8 kg) for the Sentinel! chest seal group. After premedication with butorphanol (0.1–0.3 mg/kg) and intramuscular injection of ketamine (20 mg/kg), general anesthesia was induced via facemask with isoflurane (5%) and oxygen from an MDS Matrx VMC! small animal anesthesia machine (Matrx Medical, Orchard Park, NY). Animals were then intubated with 6–7-mm endotracheal tubes and maintained on Isoflurane set at 2%, or as needed for adequate anesthesia. All subjects were allowed to breathe spontaneously for the duration of the procedure. The animals were placed in a supine position on the operating table after intubation. A Philips MP50 IntelliVue monitoring system (Philips Medical Systems, Böblingen, Germany) was used for continuous monitoring of vital parameters, including heart rate, MAP, oxygen saturation, temperature, and respiratory rate. After exposure via standard cut-down technique, the right carotid artery was cannulated with a 20-gauge catheter for continuous arterial blood pressure monitoring. The external jugular vein was cannulated with a 9Fr central venous catheter for collection of blood. As described in a previously validated model, the right front leg was gently pulled forward and secured in order to allow access to the chest. An incision through the skin was made over the fifth intercostal space just inferior to the axilla. Blunt dissection was then used to create a hole into the pleural cavity. A 10-mL syringe was cut to a barrel length of 3 cm and inserted through the hole into the pleural cavity, such that the flange rested on the skin surface. A 9Fr angiocatheter was then placed through the chest wall 10 cm from the created hole via modified Seldinger technique in order to allow air and blood injection into the chest cavity. To determine the amount of air required to induce a tension pneumothorax, air was injected via the 9Fr catheter in 60-mL aliquots into the thoracic cavity to a maximum volume of 50 mL/kg. This was discontinued by removing the plunger when the MAP decreased by 20% from baseline, or heart rate increased by 20% from baseline. The animal was observed for a 15-min recovery period, and the MAP was permitted to return to baseline. Table 2 depicts the volumes of air required to induce tension pneumothorax in each subject. The animals were randomized into three groups of eight, one group for each of the three chest seals. The seals included the HyFin! Chest Seal (North American Rescue, Greer, SC), the SAM! Chest Seal (SAM! Medical Products, Wilsonville, OR), and the Sentinel Battle Seal (Combat Medical Systems, Fayetteville, NC). Design specifications of each individual chest seal are presented in Table 3. The selected chest seal was placed Table 3. Chest Seal Specifications, Dimensions, and Characteristics Specification SAM! Chest Seal HyFin! Vent Chest Seal Sentinel! Battle Seal Dimensions (inches) Chest wall preparation device Seal design (evacuation of blood and air) Night-vision goggle–compatible 9.2 ! 7.6 Disposable gauze pad Conventional flutter valve Yes 6!6 Disposable gauze pad Laminar vent channel No 6.5 ! 6.5 Disposable gauze pad Laminar vent channel No 4 J. G. Kotora Jr. et al. over the created wound according to the manufacturer’s directions in order to test for air evacuation efficacy. As described previously, air was injected in increments of 60 mL to a maximum of 50 mL/kg. Hemodynamic parameters were monitored and recorded with an a priori stopping point of either a 20% MAP decrease, an increase in heart rate by 20% from baseline, or both. The changes in hemodynamic parameters reflect the presence of tension pneumothorax. If the hemodynamic stopping point was not reached in the presence of the chest seal, the stopping point was the 50 mL/kg of injected air maximum. After a 15-min stabilization period, the chest seal was then evaluated for efficacy in evacuating air in the presence of blood in the chest cavity. Ten percent of the total blood volume of the animal was collected from the arterial line and injected via the 9Fr catheter into the chest cavity. The animal was allowed a 5-min stabilization period, followed by an injection of air into the chest in increments of 60 mL, to a maximum of 50 mL/kg. Heart rate and MAP were again recorded until the heart rate increased by 20% from baseline or MAP decreased by 20% of baseline. Once the required change in parameters was reached or the maximum amount of air was injected (50 mL/kg), the animal was monitored for 15 min. During the stabilization periods, all of the subjects’ vital signs returned to near baseline parameters. The periods of stabilization were built into the design of the study to allow the subject’s physiology to adjust to the changes induced by each intervention. Survivors were euthanized via i.v. injection of euthanasia solution (Euthasol, Virbac Animal Health, Inc., Fort Worth, TX) in accordance with American Veterinary Medical Association guidelines for euthanasia. All three phases are presented for comparison in Table 4. Sonographic images were recorded before and after each intervention using a SonoSite 180 Plus (SonoSite, Bothell, WA). A standard C60/5 2-MHz transducer probe was placed in three standard locations over the animal’s thorax, and images were recorded at a depth of 9.9 cm. Table 4. Volume of Air Injected during Each Intervention (mL/kg) Intervention Phase 1 Air required to induce tension pneumothorax Phase 2 Air injected after chest seal placement Phase 3 Air injected after infusion of blood into thoracic cavity SD = standard deviation. Treatment Group Mean 6 SD All groups 29.0 6 11.5 HyFin! SAM! Sentinel! HyFin! SAM! Sentinel! 49.7 6 0.9 50.0 6 0.0 50.0 6 0.0 43.7 6 11.8 49.7 6 0.9 50.0 6 0.0 The placement points were forward of the created chest wound, as described by Arnaud et al. (8). Videography was unavailable at the time of the study. However, two board-certified emergency physicians credentialed in ultrasound viewed all images in real time. These physicians were study investigators, and were therefore unblinded. Air in the chest cavity can be seen as the absence of lung sliding, and a determination of lung sliding can be different at each of the three points on the chest. The ultrasound was used to detect the presence of pneumothorax and hemothorax. Sample size was determined based on Arnaud et al.’s 2008 model. Statistics were calculated with SPSS Statistics 17.0 (IBM Corporation, Armonk, NY). Results are presented as mean 6 standard deviation. A one-way analysis of variance (ANOVA) was used to analyze statistical differences among treatment groups with respect to weight, total amount of air injected for each pneumothorax phase (in mL/kg), and differences in MAPs and heart rates at each time point throughout the experiment. The Least Significant Difference post-hoc test was used for paired comparisons of group means if the ANOVA revealed a significant effect. A p value of <0.05 was considered significant. RESULTS Mean weight was significantly lower in the HyFin! treatment group compared with the SAM! (p = 0.038) and Sentinel! groups (p = 0.017). Animal size varied and was subject to the available inventory at the time of the study’s execution. However, animal size had little to do with induction of a tension pneumothorax, as all volumes were based on 50 mL/kg body weight. Baseline MAP and heart rate did not differ among groups. The volume of air required to induce a tension pneumothorax before chest seal placement was 29.0 ( 6 11.5) mL/kg, and was similar among the groups. Likewise, the air volume injected after chest seal placement did not differ between treatments, and reached the maximum volume of 50 mL/kg in all subjects in both the SAM! and Sentinel! groups. In the HyFin! group, 1 subject achieved a 20% decline in MAP with a volume of 47.7 mL/kg of air injected. However, this subject’s MAP recovered immediately upon cessation of air injection. After injection of blood into the chest cavity, most subjects again withstood the maximum volume of air injected of 50 mL/kg, with the exception of 2 subjects in the HyFin! treatment arm and 1 subject in the SAM! arm. These subjects received injections of 22.4, 26.9, and 47.4 mL/kg of air before a 20% decrease in MAP, respectively. Again, all MAPs returned to normal rapidly after cessation of air injection. Consistent with previous Chest Seals in Penetrating Trauma phases, there were no significant differences between treatment arms after this final injection of air. Chest seals in all groups vented blood after development of a hemothorax. A moderate decline in MAP attained by the HyFin! subjects after air injection during both the second and third injection phase can be visualized in Table 1. MAP in each group recovered similarly after procedures, and all subjects survived the experiment. Figure 1 displays the mean change in MAP for each subject arm over time. The only significant difference in MAP at any time point was after induction of the first pneumothorax. The Sentinel! treatment group recovered more quickly to a higher MAP than the SAM! treatment group (p = 0.003) at T + 10. However, this MAP difference was experienced before placement of the chest seals. Once seals were placed, all subjects returned to a similar MAP, and treatment groups remained similar throughout the duration of the experiment. As expected, MAP declined after creation of hemothorax consistently in all subjects. After induction of the first pneumothorax and before chest seal placement, the Sentinel! subjects demonstrated a higher mean heart rate than either the HyFin! or the SAM! groups at T + 10 (p = 0.026 and p = 0.023, respectively) and T + 15 (p = 0.025 and p = 0.040, respectively). Subsequent to chest seal placement, heart rate did not differ for the remainder of the study. A Sonosite portable bedside ultrasound was utilized to investigate the presence of pneumothorax after each intervention. There was excellent inter-rater agreement regarding the presence of a pneumothorax on ultrasound images. Because both physicians observed the ultrasound scan in real time, no kappa was necessary. Figure 1. Changes in mean arterial pressure (MAP) after each intervention over time. HTX = hemothorax; PTX = pneumothorax. 5 DISCUSSION Open pneumothorax, tension pneumothorax, and complex thoracic trauma remain a frequent mechanism of injury and preventable cause of death. Although the use of an unvented chest seal is effective at sealing an open pneumothorax, it is completely useless for prevention of a tension pneumothorax and, in the setting of positive pressure ventilation, can actually predispose to it. Improved body armor has resulted in a decreased incidence of thoracic trauma among US military members injured in Operation Iraqi Freedom and Operation Enduring Freedom. Nonetheless, the incidence of fatal tension pneumothorax has remained constant at 3%–4% of all combat casualties. This is not appreciably changed from the classic 5% reported from the Wound Data and Munitions Effectiveness Team database from Vietnam, despite numerous technological advances and a more organized trauma care system in the operational theater (10). Unvented seals require considerable monitoring and attention to both the device and the patient. The standard method of tension pneumothorax decompression is the insertion of a 14-gauge, 50-mm catheter into either the second intercostal space in the midclavicular line or the fourth or fifth intercostal spaces in the mid axillary line. Recent studies have questioned the effectiveness of needle decompression and whether one site is superior to another. In addition, these studies have examined whether a longer catheter is warranted to decrease the failure rate of needle decompression. Givens et al. reported failure of needle decompression in approximately 25% of potential attempts, based on measurements obtained via computed tomography in military personnel (11). Sanchez et al. performed a similar study in an urban trauma center, reporting failure of a 50-mm catheter in 35%–75% of patients, depending on the placement location (12). Stevens et al. and Zengerink et al. also question the reliability and efficacy of needle decompression with 50-mm catheters (13,14). The development of a tension pneumothorax is not always an easily treatable condition. Many tension pneumothoraces occur as preterminal events, unfortunately ending in cardiopulmonary collapse and arrest. These factors in the setting of multiple polytrauma patients, poor visibility, and austere conditions increase the likelihood of adverse outcomes for patients with open pneumothoraces whose chests are sealed with an unvented seal. Given the high failure rate of standard decompresion catheters, the CoTCCC now recommends the use of an 80 mm decompression needle inserted in either the 2nd intercostal space in the midclavicular line, or in the 5th intercostal space in the anterior axillary line (http://www. health.mil/dhb/downloads/62812/03_TCCC%20Needle% 20Decompression.pdf). 6 In our experience with the same model described in this study, lethal tension pneumothorax quickly developed when the same volume of air was infused into a pilot animal with an unvented chest seal applied to the wound. At present, the CoTCCC recommends the use of an unvented chest seal. However, our experience strongly argues against the use of unvented chest seals due to the increased risk of tension pneumothorax development, as well as the increased clinical attention required by the prehospital tactical medical provider. It is also important to consider the environment in which these seals are applied. Currently, the CoTCCC recommends the application of a chest seal during the Tactical Field Care and Tactical Evacuation phases (6). Although these phases of care are not conducted under effective hostile enemy fire, military and tactical civilian medical providers frequently encounter a fluid environment where small arms fire, IEDs, or strong enemy resistance might present again, causing a return to the Care Under Fire phase. Vented chest seals require less attention by prehospital tactical medical personnel than unvented chest seals, especially under these extremely adverse conditions. None of the chest seals were trimmed to fit, as described in prior studies. We believed this detracted from the external validity of the study, as this is not common practice under tactical battlefield conditions. In addition, none of the seals were reinforced with adhesive tape, because the CoTCCC requires that chest seals be self adherent in the face of blood, sweat, and debris. Although there are no documented reports of valve failure with resultant development of tension pneumothorax in vented chest seals, there are case reports of similar valves connected to indwelling chest tubes that clotted and contributed to the development of tension physiology (15). Although the valves of vented chest seals and the Heimlich valves of indwelling chest catheters share some similarities, there are stark differences. Vented seals are temporary, externally applied devices that are not intended to have direct communication with the lung pleura. This is in contrast to indwelling chest tubes. In addition, bending or fracture of the chest tube itself can contribute to tension pneumothorax development. For reasons stated here, this would clearly not be an issue for vented chest seals. Civilian emergency medical service professionals have also questioned whether vented chest seals offer a distinctive advantage over the standard three-sided seal commonly employed for open chest wounds. A recent publication in the emergency medicine literature highlights the paucity of data available. Although the data are limited, the authors suggest vented chest seals can offer some advantage over the three-sided seal with regard to practicality and ease of use (16). J. G. Kotora Jr. et al. One must note the injury model used in this study evaluated subjects with an isolated thoracic injury, and does not represent the polytrauma patient. This is often not the case in combat, and the vast majority of casualties evacuated from the battlefield sustain multiple injuries to the head and neck, upper and lower extremities, and external soft tissues. The mean Injury Severity Score for casualties transported to a level III facility in Afghanistan is 21.19 (17). Likewise, as mentioned previously, the most common mechanism of injury in Operation Enduring Freedom is blast injury from IEDs or some other explosive mechanism (1,2). Chest seal adhesion has been considered a problem when a casualty is covered with blood, sweat, dirt, grease, or sand. This has led to many tactical medical providers losing confidence in their abilities, given the high failure rates and constant need for reinforcement of the device. All three seals adhered very well on both dry and soiled skin. All three utilize a strong polyurethane disk mounted on a hydrogel base, and their adhesion is excellent even in the face of blood or debris. Unfortunately, we were unable to accurately evaluate any differences in the adhesive properties of the individual seals, as there was no objective method of quantifying adhesion to the skin in our laboratory. A device for measuring the tensile strength of the seal on skin was available at the time of the study; however, the cost of this device was prohibitive. This would be an area of future research, and would allow investigators to objectively account for differences in adhesion of various chest seals. Limitations In order to induce a hemopneumothorax, 10% of the animal’s blood volume was collected and inserted into the pleural space via the 9Fr intrathoracic catheter. Although it might be possible that the removal of blood can contribute to development of hypotension and tachycardia, the current classes of shock do not support this hypothesis. The current accepted classes of shock range from Class I through Class IV, with Class I representing <15% of the total blood volume, and Class IV representing >40%. The investigators carefully calculated the volume of blood that represented 10% of the animal’s total blood volume, and removed only the volume necessary. Based on the current classes of shock, removal of 10% would fall under Class I, and should have no effect on vital signs (18). It is important to note that the vital signs did return to near baseline shortly after the blood was removed. This can be seen in Table 1. We considered inserting a 5-min stabilization period between blood removal and insertion through the catheter, but were concerned that the blood volume removed would clot, rendering it useless. Future studies might seek to eliminate this limitation by adding Chest Seals in Penetrating Trauma a stabilization period between removal and insertion, removing the volume over a longer period of time, or possibly adding an anticoagulant to the volume of blood removed. Overall, ultrasound did not yield any significant data for the purposes of this study. At present time, ultrasound can only confirm or deny the presence of a pneumothorax, but cannot offer quantitative data regarding the volume of air or size of a pneumothorax. All three seals demonstrated persistent pneumothorax on ultrasound before euthanasia. However, the time period between the final intervention and the induction with Euthanyl was only 15 min. At present, it is unknown if a vented chest seal adequately assists in the resolution of a pneumothorax, or how much time might be required to initiate resolution. It is also important to mention that this study was completed on intubated, spontaneously breathing models without the use of positive pressure ventilation. The current system of trauma care in the deployed theater centers around three levels of care. Level II and III facilities are able to provide immediate definitive airway control. The US Marine Corps is currently utilizing emergency physicians capable of providing rapid sequence intubation and definitive airway management in some of their Level I facilities. However, at the present time this is the exception rather than the rule. The majority of Level I facilities are staffed by generalist physicians who, due to the lack of resources and equipment, are incapable of providing advanced airway techniques or positive pressure ventilation. These interventions are frequently delayed until a patient reaches the comprehensive Level III facilities, which are analogous to fully equipped trauma centers. Although critically wounded patients are ideally transported from the point of injury to Level III facilities immediately, it is not uncommon for patients in very remote or austere environments to first stop at Level I or Level II facilities for immediate care. In addition, with regard to special operations and covert missions, advanced definitive care might be unavailable for several hours or days. That being said, patients with open pneumothoraces can be intubated and placed on positive pressure ventilation, if these interventions are available before arrival at a comprehensive trauma facility. Vented chest seals are not currently indicated for ventilated trauma patients, as these patients all require tube thoracostomy while on the ventilator with a pneumothorax. The function of the valve has never been tested on intubated patients connected to a ventilator circuit. This study was performed on intubated subjects without ventilator support for two primary reasons. One, most patients with a communicating pneumothorax will initially be treated by prehospital providers with basic life-support skills. That said, it is important to determine what utility a vented chest seal has in a spontaneously breathing patient without respiratory assistance. The second reason subjects 7 were not placed on ventilators is physiological. We were concerned that production of a tension pneumothorax on a ventilated subject with a fixed tidal volume and respiratory rate would contribute to metabolic acidosis, resulting in exaggerated hemodynamic compromise. We saw this as a potential source of bias. We elected to allow the subjects to breathe spontaneously, enabling each subject to regulate its own acid–base balance. Future studies are required to determine if vented chest seals would prevent tension pneumothorax in ventilated trauma patients with communicating pneumothoraces, and what effects artificial ventilation might have on acid–base balance. Notably, this model did not test the integrity of the seal or the vent in a patient with a bronchopulmonary laceration, as is often seen in victims of blast injury. Although the development of a tension pneumothorax due to a bronchopulmonary laceration is often seen in victims of blast injuries, they are usually closed pneumothoraces. Application of a vented chest seal would not likely prevent additional cardiopulmonary insult. Additional study is required to evaluate the incidence of delayed tension pneumothorax after application of a vented chest seal in patients with a bronchopulmonary laceration. CONCLUSIONS Our study is the largest randomized, unblinded laboratory animal study evaluating the use of vented chest seals in the setting of open pneumothorax and penetrating thoracic trauma. Blinding was not possible with this study, given the experimental design of the study. At the present time, our study is the only trial that compares the most popular vented chest seals currently used by US military medical providers. This study failed to demonstrate any significant difference in valve function with regard to evacuation of air or accumulation of a tension pneumothorax. Although the seal designs varied significantly, all three devices adequately vented both blood and air from the wound. There was no clinically or statistically significant difference among individual seals. None of the animals succumbed to premature death from tension pneumothorax after seal placement. All three devices also provided confirmation of air removal through both visual and auditory cues. This is of tremendous value because medical personnel can be given immediate feedback regarding the efficacy of the device, and can reinforce confidence in the user that the individual device is functioning properly. REFERENCES 1. 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Sanchez LD, Straszewski S, Saghir A, et al. Anterior versus lateral needle decompression of tension pneumothorax: comparison by computed tomography chest wall measurement. Acad Emerg Med 2011;18:1022–6. 13. Stevens RL, Rochester AA, Busko J, et al. Needle thoracostomy for tension pneumothorax: failure predicted by chest computed tomography. Prehosp Emerg Care 2009;13:14–7. 14. Zengerink I, Brink PR, Laupland KB, Raber EL, Zygun D, Kortbeek JB. Needle thoracostomy in the treatment of a tension pneumothorax in trauma patients: what size needle? J Trauma 2008;64:111–4. 15. Paul AO, Kirchhoff C, Kay MV, et al. Malfunction of a Heimlich flutter valve causing tension pneumothorax: case report of a rare complication. Patient Saf Surg 2010;4:8. 16. Walthall K. Towards evidence-based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 3: In a penetrating chest wound is a three-sided dressing or a one-way chest seal better at preventing respiratory complications? Emerg Med J 2012;29: 342–3. 17. Nessen SC, Cronk DR, Edens J, Eastridge BJ, Blackbourne LH. US Army split forward surgical team management of mass casualty events in Afghanistan: surgeon performed triage results in excellent outcomes. Am J Disaster Med 2009;4:321–9. 18. Gutierrez G, Reines HD, Wulf-Gutierrez ME. Clinical review: hemorrhagic shock. Crit Care 2004;8:373–81. http://www.ncbi.nlm.nih. gov/pubmed/15469601. Chest Seals in Penetrating Trauma ARTICLE SUMMARY 1. Why is this topic important? Tension pneumothorax is a significant cause of morbidity and mortality in both military and civilian trauma care. Many options exist for sealing sucking chest wounds; however, none perform well in all cases. This leads to inadequate management of communicating pneumothoraces, and potentially unfavorable patient outcomes. 2. What does this study attempt to show? This study attempts to present an unbiased evaluation of three of the most popular vented chest seals currently in use by operational units of the US military. Equally important, this study utilizes a reproducible model that mimics a common injury pattern seen in both military and civilian emergency medicine practice. 3. What are the key findings? All three of the vented seals effectively evacuated blood and air. None of the subjects developed a tension pneumothorax or suffered hemodynamic compromise once the seal was in place. 4. How is patient care impacted? Vented chest seals offer emergency medicine professionals a viable option for management of open pneumothoraces and prevention of respiratory failure or death. 9
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