Je-Bog Yoo, RN. & Ph D. - Professor of Gyeonam National Univesity of Science and Technology - Dept. of Nursing Science - President of Korean association of Perianesthesia Nurses 1 Introduction Backgrounds Approximately 50 – 90% of patients who has undergone operations are known to experience hypothermia Hypothermia in operation causes various complications -delayed recovery after operation -delayed discharge from the recovery room, refer to ICU, - extended hospitalization -even additional administration of drugs or blood transfusion →which can cause extra-charge In local anesthesia the patient’s body temperature compared to the general anesthesia to overlook the risk of hypothermia 2 Backgrounds • Geriatric Patient → can’t adjust body temperature have a low compensation Hypothemia • In local anesthesia → don’t have much recognition of the lowered central body temperature Total Knee Replacement Arthroplasty Operating room temperature (20℃ below) → Surgeon’s operating gown (head gear wear) • • Apply same heating protocol → no standardized guideline To verify the effects of “ASPAN’s Evidence-based Clinical Practice Guidelines for Promotion of Perioperative Normothermia 3 Purpose For the management of hypothermia of patients Control group: received standard hypothermia management of the clinic Experimental group: received the evidence-based clinical practice guideline of ASPAN 1) To see the changes of body temperature 2) To see the changes of shivering of the subject 3) To see the changes of thermal discomforts of the subject 4 Research hypothesis 1) 11 Experimental group keep higher temperature than control group 2) 3) 4) Experimental group is smaller shivering than control group Experimental group is lower discomfort on hypothermia than control group Experimental group will be shorter to get a normal temperature time than control group 5 Study methods Study design A randomized controlled trial designed - independent variable : The evidence-based clinical practice guideline suggested by ASPAN - dependent variable : The body temperature, shivering, thermal discomfort and thermal discomfort Experimental group Control group Before operation During operation After operation T1† X T2† X T3† X T1† T2† T3† X : ASPAN's EBP Guideline during operation period in patients T1 : : the body temperature , shivering , thermal discomfort T2 : : the body temperature, shivering T3 : : the body temperature , shivering, thermal discomfort , thermal discomfort † : measured in 30 min intervals 6 Study subjects G Power 3.0 : effect size .5, power of .80, p value of .05, Patients in the age of 55~85 • For each group 33 subjects(drop-out rate 10% consider) • The inclusion criteria (1) understood the purpose of this study and made written consent (2) patients with class I and II in ASA clas (3) Patients who received spinal anesthesia, (4) Patients in normal temperature before operation (5) Patients without known drug allergy, history of drug dependence, neurologic pathology, or recent systemic or local infection. (6) Patients in the age of 55~85 7 Study endpoints Body • Measured by the tympanic thermometer which measures the deep temperature temperature • By adding heat to the tympanum and surrounding tissues by infrared Shivering Thermal discomfort • Collins tool (1996) • 5 scores of scale; 0=no sign of shivering, 1=intermittent weak shivering of jaw and neck, 2=strong shivering of chest, 3=intermittent or strong shivering of the whole body, 4=persistent and strong shivering of the muscles of whole body • Higher score means higher degrees of objective thermal discomfort due to shivering • Thermal discomfort tool developed by Kim, Chung, and Park(2008) • Total 5 scores of scale; 1=very warm, 2=warm, 3=normal(confortable), 4=cold, 5=very cold. • Expression of feelings were recorded in 30-min intervals before, after the operation Time to • The time to recover the body temperature over 36℃ since it was lowered than achieve 36℃ while staying in the recovery room after operation calculated in minutes. normothermia 8 Data collection tool and procedures (1) The effects the evidence-based clinical practice guideline suggested by ASPAN by the (2) The approval from IRB of the hospital (No. 2011-10-053) was obtained prior to the study initiation. (3) 33 pieces of paper the test group and another 33 pieces of paper the control group in one pocket and randomly picked one in the order of arrival to the operation room (4) Data were collected from 26Dec2011 until 31Mar2012. (5) Operation schedules were checked prior to the day of operation Visited the subject in the evening prior to the operation date Obtained written consent upon explaining the objective and procedures of this study Getting information about demographic information, disease, treatment-related information from the subject after the consent. 9 (6) Experimental group treatment ① Before operation Under 36℃ Over 36℃ - Clothes, towel and blanket - Bair hugger (43℃ apply) - only blankets and socks were provided as passive heating ( operation room temperature 20˜24℃) ② During operation Under 36℃ Over 36℃ - surrounded by blanket (size of 100CM X 90 CM) stored in the 50℃ incubator in the head and socks in his/her feet saline heated by ANIMAC (Elltec, Japan) set as 42℃ - heat pad(Cincinnati sub zero, Dermo temp) apply - skin exposure was minimized : operation room temperature 20˜24℃ - Thermal discomfort : didn’t check during operation ③ After operation Under 36℃ Over 36℃ - blanket and towel - Bair hugger (43℃ apply) - heated saline : ANIMAC (Elltec, Japan) set as 42℃ - passive (blanket, socks, towel, operation room temperature 20˜24℃) - Time to achieve normothermia : the time to recover the body temperature over 36℃ since it was lowered than 36℃ (7) Control group treatment Before operation During operation - 1˜2 blanket stored in the incubator - Blanket and heated pad 1~2 10 After operation • • - Under 36℃ heated blanket and towel Bair hugger (43℃ apply) Over 36℃ towel heated blanket Control and experimental group guidelines Experimental group Before operation During operation After operation Location Waiting room Operating room Postanesthesia care unit Control group ∙ apply towel ∙ measure the body temperature, shivering, thermal discomfort in 30 min intervals ∙ apply towel ∙ heated pad (Cincinnati sub zero) ∙ measure the body temperature, shivering in 30 min intervals Assess ment ∙ Assess for risk factors for perioperative hypothermia ∙ Measure tympanic temperature ∙ Measure shivering ∙ Measure thermal discomfort ∙ Assess for signs and symptoms of hypothermia and/or cold extremities ∙ Document and communicate all risk factor assessment findings to all members (SBAR) ∙ Assess for risk factors for perioperative hypothermia ∙ Measure tympanic temperature ∙ Measure shivering ∙ Assess for signs and symptoms of hypothermia and/or cold extremities∙ ∙ Document and communicate all risk factor assessment findings to all members (SBAR) Normal tempera ture intervent ion ∙ over 36℃ - passive heating - Socks for sleep, heated blanket - operating waiting room temperature 20 ~ 24℃ ∙ over 36℃ - passive heating - minimize skin exposure - operation room temperature 20 ~ 25℃ ∙ under 36℃ - passive heating - Socks for sleep, heated blanket -operating waiting room temperature 20 ~ 24℃ - active heating - Apply bair hugger ∙ under 36℃ - passive heating - minimized skin exposure -operation room temperature 20 ~ 25℃ - active heating - heated saline (ANIMAC) - heated pad (Cincinnati sub 11 zero) Hypothe rmia Interven tion ∙ measure body temperature ∙ under 36℃ - Bair hugger ∙ over 36℃ - apply heated blanket - measure the body temperature, shivering, thermal discomfort in 30 min intervals ∙ Assess for risk factors for perioperative hypothermia ∙ Measure tympanic temperature ∙ Measure shivering ∙ Measure thermal discomfort ∙ Assess for signs and symptoms of hypothermia and/or cold extremities ∙ Document and communicate all risk factor assessment findings to all members (SBAR) ∙ over 36℃ - passive heating - Socks for sleep, heated blanket - PACU room temperature 20 ~ 24℃ ∙ under 36℃ - passive heating - Socks for sleep, heated blanket - PACU room temperature 20 ~ 24℃ - active heating - Bair hugger - heated saline (ANIMAC) - Apply heated towel around head Data analysis method Data were analyzed by SAS Ver 9.2. 1) The general characteristics : in the real number, percentage, and standard deviation 2) The homogeneity test of demographic characteristics, disease-related characteristics and dependent variables : 3) The change of the effect of intervention by time - repeated measures ANOVA 12 1) Homogeneity Test of General Characteristics between Experimental and Control Groups Characteristics Categories Exp. (n=30) Cont.(n=30) Mean±SD or n(%) (N=60 ) t or χ2(p) Male 4 (13.3) 2 (6.7) Female 26 (86.7) 28 (93.3) Age (year) 70.8±5.2 70.9±5.1 -.08(.940) Height (cm) 152.4±5.4 152.0±6.6 .26(.793) Weight (kg) 66.9±9.4 65.8±8.4 .88(.092) Gender *Fisher’s exact test. : No significant difference was observed between two groups of their homogeneity * 연구 대상자의 일반적 특성의 동질성 검정 유의한 차이가 없었다 13 (.671)* 2) Homogeneity Test of Operation-related factors between Experimental and Control Groups (N=60 ) Factors Categories Exp. (n=30) Cont.(n=30) t or χ2(p) Mean ± SD or n (%) Operation time(min) 104.8±22.5 100.0±11.3 1.05(.302) Anesthetic time(min) 145.4±23.9 138.0±15.1 1.44(.156) 30 (100) 30 (100) Yes 30 (100) 30 (100.0) No 0 (0) 0 (0.0) Thoracic 1~T12 24 (80) 29 (96.7) Lumbar 1 5 (16.7) 1 (3.3) Sacrum 1 1 (3.3) 0 (0.0) Past history of Yes 19 (63.3) 12 (40) operations No 11 (36.7) 18 (60) Type of anesthesia Administration of Sedative before Anesthesia Post of spinal Anesthetic level spinal anesthesia (.103)* 3.27(.071) •Fisher's exact test : No significant difference in the operation-related factors between two groups of their homogeneity 14 3. 체온 Exp. Con. Pre-op. Intra-op. Post-op. min. Adm. 30min. Adm. 30min. 60min. 90min. 120min. Adm. 30min 60min. dis. Difference in body temperature between two groups (p= .002) No change by time(p= .882) No change by interaction between group and time (p= .173) The temperature of the Experimental group was higher than the control group by 0.2-0.4˚C 15 Pre operative period Valuables Admission to waiting Post 30 min room shivering Intra operative period Post operative period Discharge from Admission to operation 30min 60min 90min 120min Adm 30min 60min Recovery F p group 0.16 .693 time 0.54 .860 0.27 .987 Sources room room Exp. 0 0 0 0.1±0.3 0±0.2 0.1±0.3 0.1±0.3 0.1±0.3 0 ± 0.2 0 0 Cont. 0 0 0 0.1±0.3 0.1±0.3 0.1±0.3 0±0.2 0.1±0.3 0 0 0 (point) group* time No difference in shivering between two groups during the whole course of the operation(p=.693) No change by time (p=.860) No interaction between groups and time (p=.987) 16 point point Exp. Exp. Con. Con. Pre-op. Post-op. min Adm. min 30min Adm. 30min 60min ANOVA showed difference in thermal discomfort between two groups (p=.034) The difference by time (p=.041) No interaction between group and time (p=.438) 17 Dis. Experimental Characteristics ( n=13) Control ( n=17) t p 4.14 .010 Mean ± SD or n (%) Time (minutes) 35.4 (±49.1) 68.3 (±58.2) -The experimental group took 35.4minutes to achieve normothermia while the control group took 68.3minutes. -The experimental group recovered normothermia significantly faster than the control group( p=.010). 18 Body temperature • Sessler(2000) demonstrated that active warming measures such as warmed IV fluid and warmed gel pad must be initiated to maintain normothermia as the body temperature of a patient decreased about 1~1.5℃ during first one hour after general anesthesia and keeps decreasing even after 2~3 hours. Shivering • In this study the method of forced air convection warming after the admission to the post-anesthetic care unit was applied equally to the patients of both groups whose body temperature was better than 36 ℃. • The fact that no difference between both groups was found in terms of shivering and little shivering occurred is thought to be owing to implementation of the effective patient treatment from hospital rooms used in the study. 19 Thermal discomfort • With respect to thermal discomfort, significant difference was found between the experimental group and the control group. Also change according to time elapsing took place, but no interaction between the groups and time elapsing was found, the result of which is assumed to be attributable to no measurement of thermal discomfort in the intra-operative period. Time to achieve normothermia • By remarkably reducing 32.9 minutes in terms of time to achieve normal body temperature compared to the control group, the systematic and individualized ASPAN’s guidelines were proven very effective by this study. 20 S Hospital • The patients of this study maintained relatively normal temperature regardless of the groups. which is thought to be owing to effective management of body temperature in the wards of the hospital. . Meaningfulness • The first application of ASPAN’s evidence-based clinical practice guidelines by nurses in Korea for the preoperative, intraoperative and postoperative periods was verified to be effective in managing hypothermia for elderly patients undergoing TKRA. 21 Temperature : The difference between two groups was observed (p=.002), No change by time (p=.882) Interaction between group and time was observed (p=.173). Body Temperature of the experimental group was higher than the control group. Shivering : There was no difference in shivering between two groups during the whole course of the operation(p=.693), no change by time (p=.860), no interaction between groups and time(p=.987). Hypothesis that less shivering would be observed in the experimental group than the control group was not supported. Thermal discomfort : The difference between two groups was observed(p=.034), By time were observed(p=.041), there was no interaction between group and time (p=.438) Thermal discomfort of the experimental group was less than the control group. Time to achieve normothermia The difference between two groups was observed(p=.010) Time to achieve normothemia was shorter in the experimental group than the control group. 22 As a result of this study, the ASPAN's EBP Guidelines were verified to have features of being relatively more effective in maintaining the intraoperative body temperature, lowering the thermal discomfort, and more quickly arriving at the normal body temperature from the hypothermic state than the conventional hypothermia management method. The present study was an experimental study with a randomized controlled trial design which attempted to examine the effective and systematic hypothermia management method through the assessment of body temperature, shivering, thermal discomfort and time to achieve normal body temperature by applying the ASPAN’ s evidence-based clinical practice guidelines targeting patients who receive TKRA under spinal anesthesia. 23 Future researches should be incorporated in a diverse fashion, by measuring the body temperature in 10 minute interval to observe more clear tendency of change in the preoperative body temperature and time to achieve normal body temperature. By conducting repetitive studies targeting patients in need of at least one hour operation under local anesthesia or under general anesthesia or targeting physically feeble children or adults. 24 Age-related thermoregulatory differences during core colling in humans. Am J Physical Regulatory Intergrative Comp Physiology, 279: 349-354, 2000. Frank SM, Fieisher LA, Breslow MJ, et al. Perioperative maintenance of normothermia redeuces the incidence of morbid cardiac events: Arandomized clinical trial. JAMA, 277: 1127-1134. 1997. Giuffre, M., Heidenreich. T., & Pruitt, L. (1994). Rewarming cardiac surgery patients: Radiant heat versus forced warm air. Nursing Research, 43, 174-178. Guyton(Ed). Texbook of Medical physiology(831-843) Philadelphia : Saunders. Houdas Y. & Ring E.F.J. (1982) Human body temperature : Its measurement and regulation, PLENUM Press, New york and London. 25 Thank you for attention ! 26
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