MANUAL IN-EXSUFFLATION (MI:E) PHILIPS E70 Guidelines for MI:E (Philips E70) in Adult Patients Guideline Profile Version 1.1 Respiratory Physiotherapy Team (Vicky Mummery / Daisy Author Cosker) Executive sponsor Patrice Hill, Director of Therapies Executive sponsor sign off July 2016 Target audience Physiotherapists Date issued Aug 2016 Review date Aug 2018 Consultation and approval Nikki Webster Principal Dates June 2016 Physiotherapist Patricia Hill, AHP Lead and Dates June 2016 Key individuals and Director of Therapies committees consulted Alison Gordon, Clinical during drafting Specialist Physiotherapist Dates July 2016 UCLH Dates Dates Ratification Ratification Committee Therapies Clinical Governance Group Date Aug 2016 Document History Version Date Review date Reason for change Page 1 of 17 Contents 1 Introduction .................................................................................................................... 4 2 Purpose ......................................................................................................................... 4 3 Scope ............................................................................................................................ 4 4 Roles and Responsibilities ............................................................................................. 4 4.1 Staff ........................................................................................................................ 4 4.2 Respiratory Physiotherapy Team ............................................................................ 5 5 Indications and Contraindications .................................................................................. 6 5.1 Indications for Use .................................................................................................. 6 5.2 Absolute Contraindications ..................................................................................... 6 5.3 Relative Contraindications ...................................................................................... 7 6 Equipment...................................................................................................................... 8 6.1 Location of Equipment ............................................................................................ 8 6.2 Equipment Setup .................................................................................................... 9 6.3 Cleaning ................................................................................................................. 9 6.4 Home Screen ........................................................................................................ 10 6.5 Modes ................................................................................................................... 10 7 Procedure .................................................................................................................... 11 8 Development and implementation ................................................................................ 13 8.1 Development......................................................................................................... 13 8.2 Implementation ..................................................................................................... 13 9 Monitoring compliance ................................................................................................. 13 10 References ............................................................................................................... 14 11 Appendix I MI:E (E70) Competency Assessment ..................................................... 16 Page 2 of 17 Executive Summary This guideline identifies the expected standard of care at St George’s University Hospital NHS Foundation Trust for the use of Philips E70 MI:E with adult patients. It identifies: Indications for use Contraindications Setup of device Documentation Competency The guideline was constructed and reviewed by the Respiratory Physiotherapy Team. It covers all clinical areas where an adult patient may visit. The target patient group includes adult patients requiring an MI:E device. The target professional group is any respiratory competent physiotherapist. Page 3 of 17 1 Introduction Mechanical Insufflation-Exsufflation (MI:E) is the use of gradual increase in positive airway pressure which rapidly changes to negative pressure. The rapid shift in pressure produces a high expiratory flow, simulating a natural cough. The E70 Cough Assistor Device can be used to augment the patient’s ability to cough and therefore assist bronchopulmonary secretion clearance. Some patients are unable to cough or clear airway secretions effectively due to reduced peak cough flow (<270l/m). MI:E is an alternative to suctioning providing decreased mucosal trauma and increased patient comfort. The E70 is typically used in neuromuscular disease however it can be used in the management of any patient in which cough effectiveness has been reduced and who are at risk of developing further respiratory complications. 2 Purpose To standardise practise across St George’s Healthcare NHS Trust To ensure a safe, evidence based rationale and procedure for Manual Hyperinflation To provide Staff with the information necessary to become trained and competent in the use of the E70 for MI:E 3 Scope This guideline applies to all staff (temporary and permanent) working in any of the locations registered by St. George’s Healthcare NHS Trust with the Care Quality Commission (CQC) to provide regulated activities. Locations are not necessarily geographically based or determined. Therefore, the term locations does not just refer to Trust buildings; it is the term used by the CQC to describe the hub of operations for a service or range of services and so includes all activities being performed in the course of performing one’s role. 4 4.1 Roles and Responsibilities Staff Staff who undertake the administration of MI:E must be employed in a clinical post within the Trust. They must be supported by their manager and be confident and willing to undertake this activity as a key part of their role. Page 4 of 17 Staff should be aware of the guidelines and how to implement them accordingly. It is the staff members’ responsibility to remain up to date with these local policies and guidelines for the use of MI:E in the adult patient. Be familiar with and demonstrate a working knowledge of policies and procedures relating to MI:E, its complications and patient assessment. Staff members using MI:E must provide evidence of continued competency in knowledge and skills through regular practice or attendance at competency training days. Competency will be assessed and recorded using the standardised MI:E Competency Assessment Form (Appendix I). Staff members using MI:E must accept appropriate accountability/responsibility for their practice. It is the responsibility of staff members using MI:E as a treatment method to document all care provided in the patient’s clinical records. 4.2 Respiratory Physiotherapy Team It is the responsibility of the Respiratory Physiotherapy Team to ensure annual MI:E competency training is available to all Physiotherapists on call at St George’s Heathcare NHS Trust. It is also the responsibility of the Respiratory Physiotherapy Team to the review and update these guidelines accordingly Page 5 of 17 5 Indications and Contraindications These are guidelines only and clinicians should use their clinical judgement in their interpretation and application. The rationale for the use of a MI:E device should be clearly documented in the patient’s medical notes. As with any therapeutic management, there are indications and contraindications that must be taken into consideration. 5.1 Indications for Use Sputum retention, typically due to: Respiratory muscle weakness (RMW) Reduced Peak Cough Flow (PCF) <270lpm Bulbar muscle involvement preventing the ability to breath-stack Typical patients requiring MI:E present with the following conditions: 5.2 Motor Neurone Disease Spinal muscular atrophy Muscular dystrophy Myasthenia gravis Post-Polio Syndrome Spinal cord injuries CVA Chronic respiratory disease e.g. bronchiectasis, cystic fibrosis Absolute Contraindications Undrained pneumothorax Severe bronchospasm Head injury with ICP > 25mmHg Severe arterial hypotension Trache-oesophageal fistula Significant haemoptysis Page 6 of 17 5.3 Relative Contraindications Proximal bronchial tumor/obstruction Risk of gas trapping or causing trauma Emphysematous Bullae Increases risk of pneumothorax Recent oesophageal or lung surgery e.g. lobectomy/pneumonectomy High airway pressure may compromise the anastamosis. Check with surgeons regarding stump pressure Spinal instability Risk/benefit must be assessed and consent to treat from treating Consultant required. Use of MI:E must be justified and other potential treatments exhausted prior to use. Full spinal immobilization (Miami J/head hold/thoracic counter pressure, etc.) required throughout treatment Severe exacerbation of Chronic Obstructive Pulmonary Disease (COPD) / Bronchospasm Increased airway pressure will increase airway irritation and inflammatory response Acute Respiratory Distress Syndrome (ARDS) / Acute Lung Injury / contusions Increases risk of pneumothorax/barotrauma Raised intracranial pressure (ICP) Increasing intrathoracic pressure compromises mean arterial pressure leading to compromised cerebral perfusion pressure Hypotension (Systolic <80) Increased intrathoracic pressure compromises venous return – reduces cardiac output Cardiovascular (CVS) instability/arrhythmias Reduces venous return - further increases effort required to maintain adequate tissue perfusion Acute Head Injury See raised ICP Unexplained haemoptysis May be indicative of acute trauma to the lung parenchyma Extreme tachypnea Difficult to co-ordinate the technique Subcutaneous Emphysema May indicate the presence of a pneumothorax Recent meal / gastric distension May induce vomiting Undrained pleural effusion May cause barotrauma to lung parenchyma Recent facial fractures, maxfax surgery or burns Precludes the use of a facemask Unclipped cerebral aneurysm Vigourous coughing can cause rupture Page 7 of 17 6 6.1 Equipment Philips E70® Cough Assistor Power cable Smoothbore tubing (1.5m) Entrainment connector if required Suitable interface (anaesthesia facemask or catheter mount) Ensure the mask fits your patient appropriately to avoid unnecessary air leaks and maximise efficiency of treatment Location of Equipment The E70 is stored in the Respiratory store cupboard located in the Physiotherapy Department St. James’ Wing Anaesthesia masks are usually located at each of the Intensive Care Units. Please speak to a nurse in charge in order to obtain one. Page 8 of 17 6.2 Equipment Setup 6.3 Cleaning A bacterial filter should be placed between patient circuit and device. If you are treating a patient with suspected H1N1, a filter should be placed at the device end and also at the distal end of the circuit before the interface to double-filter and protect the device. Tubing, masks and filters are single patient use and therefore should be disposed of as per infection control Policy. After each patient use, the exterior of the machine may be washed with a mild detergent and water, or with a bactericidal cleaning solution such as 70% isopropyl alcohol as per infection control Policy and stored in its appropriate bag. A green Clinell® green sticker should be applied to demonstrate that the device has been sanitised. Page 9 of 17 6.4 Home Screen 3 4 1 5 2 1. Left Button Allows selection of certain actions specified on-screen 2. Up/Down Button Allows navigation of the display menu and editing of device settings 3. Manual Switch Switch activates the exhale and inhale phases. Press right (+) to activate the inhale phase; press left (-) activates the exhale phase. Leaving the switch in the middle activates the pause phase 4. Power On/Off Turns the device on or off 5. Right Button Allows selection of certain actions specified on-screen 6.5 Modes Manual Insufflation / Exsufflation is controlled manually by treating therapist Auto Insufflation / Exsufflation is auto cycled. Inhale time, exhale time and pause time can all be set CoughTrak Can be added to Auto mode. Insufflation / Exsufflation is automated but triggered by the patietns insirpatory effort. Inhale time, exhale time and pause time can all be set Osscillation Can be added to Auto and Manual modes either during inhale, exhale or both phases to mobilize and increase the benefits of therapy Page 10 of 17 7 Procedure PREPARATION Action 1. Perform a thorough assessment of the patient to ascertain whether MI:E is indicated 2. Wash hands and apply suitable PPE 3. Assemble equipment and complete safety checks including machine filter check (back of unit) 4. Select appropriate interface and ensure good fit if using facemask 5. Select appropriate Mode (Manual / Auto / CoughTrak) 6. Set up machine to desired settings (Insufflation Pressure, Exsufflation Pressure, Inhale Flow and if in Auto Mode: Inhale Time, Exhale Time and Pause Time) 7. Explain the procedure to the patient and the rationale behind it Familiarise patient with mask, especially if unfamiliar with positive pressure therapy 8. Position the patient to optimise treatment i.e; lung to be treated should be uppermost to aid postural drainage Rationale MI:E has the potential to be distressing for patients therefore only use an indicated Infection Control Ensure the equipment is undamaged and correctly configured for use To prevent leaks Set Exsufflation to at least 10cmH2O below the equivalent insufflation pressure, e.g. Insufflation pressure 30cm H2O Exsufflation pressure - 40cm H2O To gain informed consent and improve tolerance of the technique Some patients like to feel the mask on their face prior to use MI:E is best performed in the sitting position, although it may be performed supine if necessary, particularly if postural drainage is expected to aid secretion clearance PERFORMING MI:E Page 11 of 17 Action Rationale 1. Apply appropriate interface allowing time for patient to become accustomed to it Ensure a tight seal is made by lips or facemask To improve tolerance of the technique To reduce leak 2. Start with a low pressure insufflation (usually 1015cm H2O) until the patient has accommodated and gradually build up to the maximum inspiratory pressure tolerated MANUAL: insufflation is achieved through pushing the manual control lever to the inhalation phase (left) for as long as the patient can tolerate (2-3 secs) AUTO: push the therapy button and device will cycle automatically 3. Release the lever and allow patient to passively exhale, whilst keeping mask on 4. Repeat for 3-6 inhalation breaths or as required Observing the patient’s chest raising or expanding while receiving MI:E will provide visual cue as for the effectiveness of our treatment For lung volume recruitment 5. Following final inhalation, rapidly switch lever to exhalation phase (right) whilst encouraging patient to cough 6. Apply suction if required 7. Once tolerating, treat in cycles of 5-6 breaths allowing patient to rest for a short period between Best Practice If cough remains inadequate, combine exsufflation with Manually Assisted Cough Consider combining MI:E with medication to lose secretions to facilitate sputum clearance 8. Deliver re-recruitment breaths post treatment MI:E can cause derecruitment 9. Monitor patient’s reaction, comfort, and response to the treatment. MonitoringSpO2, HR, RR and BP required In order to review settings or continue/discontinue treatment To ascertain clinical changes Note: Consider RR and breath ratio when determining the times for Insufflation and Exsufflation. Some patients will like simple sequences of Insufflation-Exsufflation; others will prefer longer Insufflation periods before the Exsufflation Considerations for use with trache patients Tracheostomy cuff should be inflated during therapy Higher exhalation pressures may be required to overcome the increased resistance of the tracheostomy tube Ensure that suction is available; the patient can be suctioned through the tracheostomy mount or mount removed and suctioned straight into the tracheostomy Page 12 of 17 8 8.1 Development and implementation Development The following guideline has been constructed by systematically reviewing the current, available literature, together with advice and discussion with expert colleagues, both in medical, physiotherapy and nursing professions. Where the evidence exists to support clinical practice it has been used and cited: Embase (1998-2016) Cochrane database of systematic reviews AMED (1985-2016) 8.2 Implementation Training will be provided by staff competent in the procedure. The Competency Checklist (Appendix I) will be used by the trainer when assessing competence and acts as a record of competency gained 9 Monitoring compliance This guideline will be monitored on an on-going basis through data collected via the Trust’s Adverse Incident Reporting Policy and through audit. Any adverse incidents relating to the E70 will be escalated and where appropriate, investigated under the Trust’s Serious Incident Policy (SI) with conclusions formed as to how the incident occurred and recommendations for change. This guideline will be updated accordingly to reflect any recommendations made. The table below outlines the process for monitoring compliance with this document Page 13 of 17 10 References Phillips, Respironics. ‘Cough Assist E70 – mechanical insufflator exsufflator’ Brochure Available online at: http://www.philips.co.uk/healthcare/product/HC1098159/coughassist-e70-mechanicalinsufflatorexsufflator Chatwin, Michelle (2008) ‘How to use a mechanical insufflator-exsufflator’ Breathe Vol 4 No 4 pp 321-329 Available online at: http://breathe.ersjournals.com/content/breathe/4/4/320.full.pdf National Institute of Clinical Excellence (2016) ‘Motor neurone disease: assessment and management’ Available online at: https://www.nice.org.uk/guidance/ng42 Homnick, D. (2007) ‘Manual insufflation-exsufflation for airway mucus clearance’ Respiratory Care Vol 52 No 10 pp 1296-1307 Available online at: http://rc.rcjournal.com/content/52/10/1296.full.pdf Toussaint, M. (2011) ‘The use of mechanical insufflation-exsufflation via artificial airways’ Respiratory Care Vol 56 No 8 pp 1217-1219 Available online at: http://rc.rcjournal.com/content/56/8/1217.full Chatwin M, Ross E, Hart N, Nickol AH, Polkey MI, Simonds AK (2003) ‘Cough augmentation with mechanical insufflation/exsufflation in patients with neuromuscular weakness’ Eur Respir J 21 pp 502-508 Available online at: http://www.ncbi.nlm.nih.gov/pubmed/12662009 Winck JC, Goncalves MR, Lourenco C, Viana P, Almeida J, Bach JR (2004) ‘Effects of mechanical insufflation-exsufflation on respiratory parameters for patients with chronic airway secretion encumbrance’ Chest 126 pp 774-780 Available online at: http://www.ncbi.nlm.nih.gov/pubmed/15364756 Page 14 of 17 Monitoring compliance and effectiveness table – must be completed prior to ratification Element/ Activity being monitored Lead/role Methodology to be used for monitoring Frequency of monitoring and Reporting arrangements Acting on recommendations and Leads Change in practice and lessons to be shared Correct use of E70 for MI:E The Principal Cardiorespiratory Physiotherapist will lead on all aspects of monitoring This guideline will be monitored on an on-going basis through data collected via the Trust’s Adverse Incident Reporting Policy and through audit. This guidelines will be reviewed a minimum of two yearly The Respiratory Physiotherapy Team will undertake subsequent recommendations / action planning for any or all deficiencies and recommendations within reasonable timeframe Required changes to practice will be identified and actioned within a specific timeframe. The Principal Cardiorespiratory Physiotherapist take each change forward where appropriate. Lessons will be shared with all the relevant stakeholders. . Any adverse incidents relating to E70 will be escalated and where appropriate, investigated under the Trust’s Serious Incident Policy (SI) with conclusions formed as to how the incident occurred and recommendations for change. This guideline will then be updated accordingly to reflect any recommendations made. The lead or committee is expected to read and interrogate the report to identify deficiencies in the system and act upon them. Required actions will be identified and completed in a specified timeframe. Page 15 of 17 11 Appendix I MI:E (E70) Competency Assessment The following statements are designed to indicate competence to use this device. Responsibility for use remains with the user, so if you are in any doubt regarding your competence to use the device, you should seek education to bring about improvement You must meet all applicable criteria before competence is confirmed Circle the answer appropriate to each criterion to verify the competence of the subject Surname: Forename(s): Title: Job Title/Designation: Division Team / department Risk Category: High Risk Assessment Date: High Risk devices must be assessed by an Authorised Trainer. You hold individual responsibility for ensuring your continuing competence Circle the answer appropriate to each criterion to verify the competence of the subject THEORY and RATIONALE a. Able to identify indications for using MI:E Met Not met b. Able to explain physiology of technique Met Not met c. Able to identify patient groups likely to benefit from MI:E Met Not met d. Able to identify contraindications and precautions of use Met Not met e. Identify appropriate outcome measures to evaluate treatment Met Not met Met Not met g. Apply appropriate modes / settings for MI:E and discuss rationale Met Not met h. Apply any relevant infection control precautions Met Not met i. Apply the technique correctly Met Not met j. Adjust settings according to patient tolerance / clinical presentation Met Not met Ability to perform INTERVENTION appropriately f. Set up E70 correctly including O2 entrainment if necessary MONITORING and REASSESSMENT k. Appropriate monitoring of patient observations during treatment Met Not met l. Appropriate outcomes re-assessed Met Not met m. Accurate and timely documentation Met Not met Signed Assesse Signed Assessor Page 16 of 17 Notes for MI:E (E70) Competency Assessor Assessment Statement Rationale a. Sputum retention typically due to: Respiratory muscle weakness Reduced PCF Bulbar muscle involvement preventing the ability to breath-stack b. Be able to explain definition as utilising a gradual increase in positive airway pressure which rapidly changes to negative pressure. The rapid shift in pressure produces a high expiratory flow, simulating a natural cough Motor Neurone Disease Spinal muscular atrophy Muscular dystrophy Myasthenia gravis Post-Polio Syndrome Spinal cord injuries Acute Exacerbations of CLD where cough is ineffective due to severe fatigue Relative Contraindications Proximal Tumor/obstruction Emphysematous Bullae Recent oesophageal or lung surgery e.g. lobectomy/pneumonectomy Spinal instability Severe exacerbation COPD/ Bronchospasm ARDS Raised ICP Hypotension / CVS instability / arrhythmias Acute Head Injury Unexplained haemoptysis High respiratory rate Subcutaneous Emphysema Recent meal Undrained pleural effusion Recent facial fractures, maxfax surgery / burns c. d. e. f. g. Absolute Contraindications Undrained pneumothorax Severe bronchospasm Head injury with ICP > 25mmHg Severe arterial hypotension Trache-oesophageal fistula Significant haemoptysis Sputum volume SpO2 Ausc Correct assembly of circuit without prompts Correct selection and adjustment of settings without prompts Gloves and gown (visor optional) Appropriate techniques demonstrated with senior present Can discuss rationale behind potential adjustments required to settings k. Appropriate monitoring throughout Rx l. Description of assessed outcome measures selected at point d. m. SOAP notes in line with trust and CSP standards Correctly attaches oxygen entrainment and bacterial filter. Correct selection of appropriate interface Mode, Insufflation Pressure, Exsufflation Pressure, Inhale Flow and if in Auto Mode: Inhale Time, Exhale Time and Pause Time h. i. j. Patient safety Legal requirement Page 17 of 17
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