The Use of Non-Invasive Ventilation in Patients with Acute Type 2 Respiratory Failure

POLICY UNDER REVIEW Please note that this policy is under review. It does, however, remain current Trust policy subject to any recent legislative changes, national policy instruction (NHS or Department of Health), or Trust Board decision. For guidance, please contact the Author/Owner. The Use of Non-Invasive Ventilation in Patients with Acute Type 2 Respiratory Failure V1.0 May 2014 Page 1 of 17

Table of Contents 1. Introduction... 3 2. Purpose of this Policy/Procedure... 3 3. Scope... 3 4. Definitions / Glossary... 3 5. Ownership and Responsibilities... 3 5.3. Role of the Managers... 4 5.4. Role of Individual Staff... 4 6. Standards and Practice... 4 6.1. Selection criteria... 4 6.10. Set Up... 5 6.30. Monitoring... 7 6.36. Escalation... 7 6.38. Treatment Duration and Weaning from Ventilation... 8 6.43. Palliation... 8 6.45. Trouble Shooting... 8 7. Dissemination and Implementation... 8 8. Monitoring compliance and effectiveness... 8 9. Updating and Review... 9 10. Equality and Diversity... 9 10.2. Equality Impact Assessment... 9 11. References... 9 Appendix 1. Governance Information... 10 Appendix 2. Initial Equality Impact Assessment Form... 12 Appendix 3. RCHT care plan and pathway... 14 Page 2 of 17

1. Introduction 1.1. Non-invasive ventilation (NIV) in the management of acute type II respiratory failure represents one of the major technical advances in respiratory care over the last decade. It has been shown to improve survival, reduce need for invasive ventilation and ICU, reduce length of hospital stay, reduce complication rates and reduce hospital costs 1. 1.2. This version supersedes any previous versions of this document. 2. Purpose of this Policy/Procedure 2.1. The aim of this policy is to provide guidance for all healthcare professionals involved in the delivery of acute NIV and to ensure that this is done both safely and effectively. This policy has been written in keeping with national evidence-based guidelines 2,3 This policy is not intended for patients on long-term domicillary NIV. 3. Scope 3.1. This policy is intended for healthcare professionals involved in the decision to implement NIV (clinicians) and those delivering NIV (clinicians, trained staff). 4. Definitions / Glossary 4.1. The following abbreviations will be used throughout this document ABG Arterial blood gas NIV Non-invasive ventilation IPPV Invasive positive pressure ventilation BiPAP Bilevel positive pressure ventilation CPAP Continuous positive pressure ventilation CCU Coronary Care Unit ph ph PaO2 Arterial oxygen tension PaCO2 Arterial carbon dioxide tension PtCO2 Transcutaneous carbon dioxide HR Heart rate RR Respiratory rate 4.2. The following terms will be used throughout this document 4.3. BiPAP Focus, BiPAP Vision and BiPAP V60 are the three types of ventilator used outside of critical care. It is mandatory for all staff delivering NIV to undergo training. Appendix 3, provides details on each separate ventilator which can be used as a reference. 5. Ownership and Responsibilities 5.1. This guideline has been developed by Dr Meme Wijesinghe, consultant chest physician, RCHT with input from the other four RCHT chest physicians (Jon Myers, Ian Coutts, Stephen Iles, Lisa Hosking). It has been based on standards set by the British Thoracic Society and Royal College of Physicians2,3 Page 3 of 17

5.2. It has been endorsed by Critical Care and the Emergency Medicine Department. 5.3. Role of the Managers Line managers are responsible for: Ensuring the policy is adhered to Provisions are made to deliver the service 5.4. Role of Individual Staff All staff members are responsible for: Delivering safe and effective NIV as stated in the policy Ensuring they are up-to-date with training and competencies 6. Standards and Practice 6.1. Selection criteria 6.2. The RCHT NIV care plan and pathway (appendix 4) must be followed and completed from selection of patients for NIV, initiation of treatment and monitoring whilst on NIV. This must be signed by the clinician and nursing staff delivering NIV. 6.3. Prior to starting NIV, patients must receive immediate maximum standard medical treatment which should include controlled oxygen therapy in all patients to keep SpO2 88-92% (refer to Emergency Oxygen Policy) for no more than one hour. 6.4. If a respiratory acidosis (PaCO2>6kPa, ph <7.35 7.26) persists in the following patients, NIV should be considered: Acute exacerbations of COPD Obesity hypoventilation syndrome Neuromuscular disease Chest wall deformity Cardiogenic pulmonary oedema unresponsive to CPAP 6.5. They must also meet the following inclusion and exclusion criteria 6.6. Inclusion Criteria for NIV Sick but not moribund *Able to protect airway *Conscious and cooperative No excessive respiratory secretions Potential for recovery to quality of life acceptable to the patient Patient s wishes considered Page 4 of 17

6.7. *Consider NIV if unconscious and endo-tracheal intubation deemed inappropriate or NIV is to be provided in a critical care setting. There are data to support the use of NIV in patients who are in a state of coma secondary to hypercapnoea and who respond rapidly to this treatment 6.8. Exclusion criteria for NIV facial burns/trauma/recent facial or upper airway surgery vomiting fixed upper airway obstruction undrained pneumothorax upper gastrointestinal surgery inability to protect the airway copious respiratory secretions life-threatening hypoxaemia haemodynamically unstable requiring inotropes/pressors (unless in a critical care unit) severe co-morbidity confusion/agitation bowel obstruction Patients with any of the above comorbidities should be discussed with the consultant responsible for the patient (critical care, cardiology, respiratory, medicine) before commencing NIV. NIV may be commenced if deemed to be appropriate in individual situations. 6.9. Patients with a ph <7.26 should be discussed with Critical Care if deemed appropriate by the admitting clinician 6.10. Set Up 6.11. Location 6.12. Acute NIV should only be delivered in the following areas: Emergency Department, Critical Care, Wellington Ward and Coronary Care Unit. For those patients in the ED who require NIV, a bed should be identified on Wellington, Critical or CCU and the patient must be transferred as soon as possible. During office hours (Monday to Friday 0830 to 1630) the NIV outreach physio should be contacted on bleep 3084. All patients should be on a cardiac monitor for the first 24 hours of treatment. 6.13. Patients on CCU who are in pulmonary oedema and do not respond to standard medical treatment should be commenced on CPAP first and only put on BiPAP if they fail to respond. Where possible, only patient with pulmonary oedema should be managed on CCU, all other patients should be managed on Critical Care or Wellington. If there are no beds available on Critical Care or Wellington, non-cardiac patients on NIV should be under the care of a nominated respiratory consultant. 6.14. If NIV is initiated elsewhere in the hospital, the NIV outreach team, critical care outreach or other appropriately trained staff (site coordinator, hospital at night) will need to remain with the patient until a bed is identified on Wellington, Critical Care or CCU. If patients develop acute hypercapnic respiratory failure at any site outside Page 5 of 17

Treliske their medical management should be optimised and if NIV is deemed appropriate they should be transferred to Treliske. 6.15. Continuous positive pressure airway ventilation (CPAP), is outside the scope of this policy, but should only be delivered on the coronary care unit or Critical Care. 6.16. Decision to start treatment 6.17. The decision to commence NIV should only be made by a doctor of ST level 2 or above. The initiation of NIV should only be performed by a health care professional trained and competent in the set-up of NIV. All patients initiated on NIV should be reviewed by a respiratory physician as soon as is practicable. The patient s consent should be sought wherever possible. Written information about NIV should be provided to patients and/or the relatives (See patient information leaflet: NIV The Treatment Explained) 6.18. All patients must have a CXR to exclude a pneumothorax or other comorbidity excluding them from NIV. If a pneumothorax is identified it must be drained prior to starting treatment. 6.19. Mask fit and positioning 6.20. The patient should be in a sitting leaning forward, or semi-recumbent position when started on NIV. Mask size should be assessed using the templates provided with the masks. A full-face mask should be used for most patients for the first 24 hours followed by switch to a nasal mask for patient comfort when requested. Only Respironics masks and disposables should be used. 6.21. Ventilators and starting pressures 6.22. Only Respironics Vision, Focus and V60 machines are to be used in the trust. All machines used outside of Critical Care must be fitted with a red plug. Plugs should be only removed by a member of staff who has been fully trained in the use of NIV. 6.23. Patients should be commenced on an initial inspiratory positive airway pressure (IPAP) of 10cms H2O and expiratory positive airway pressure (EPAP) of 5cms H2O. These pressures may not significantly improve gas exchange but allow acclimatization of the patient to the machine. The IPAP should be gradually increased by 2-5cm increments at a rate of approximately 5 cms H2O each 10 minutes until a therapeutic response is achieved or patient tolerability has been reached. An IPAP of 20cmH2O should be therapeutic in most patients, but should be assessed with ABGs. Patients who are morbidly obese are likely to need a higher target IPAP. 6.24. Other treatments 6.25. Oxygen should be entrained to achieve a saturation of 88-92%. The BiPAP Vision and BiPAP V60 allows a precise fraction of inspired oxygen to be delivered, whereas the BiPAP Focus provides a variable oxygen concentration. Oxygen should not be directly entrained into the mask as lower oxygen concentrations are delivered to the patient. Page 6 of 17

6.26. Bronchodilators should preferably be administered off NIV but may be administered on NIV and when so should be entrained between the expiration port and the face mask. Delivery of both oxygen and nebulised solutions is affected by NIV pressure settings. 6.27. Non-invasive ventilation can be used with a naso-gastric tube in place, in which case this should be a fine bore tube to minimise mask leakage. 6.28. Infection Control 6.29. Equipment should be cleaned according to manufacturer and Infection Control guidelines. A bacterial filter must be attached to the ventilator outlet port. This should be changed between patients and at 24 hour intervals. The filters in the machine s air entrainment mechanism should be changed when visibly dirty and between patients. Single patient use items should not be reused and should be disposed of appropriately. A system should be in place to enable traceability of equipment e.g. in the event of product failure to enable recall of equipment. 6.30. Monitoring 6.31. All patients receiving NIV require continuous cardiac monitoring for the first 24 hours of treatment. Thereafter the need for cardiac monitoring should be risk assessed. 6.32. RR, HR, level of consciousness, chest wall movement, ventilator synchrony, accessory muscle use, patient comfort, and SpO2 must be monitored and recorded at the following intervals: First hour: every 15 minutes 1-4 hours: every 30 minutes 4-12 hours: every 1 hour After 12 hours of treatment patients should have hourly observations whilst on NIV but this can be reduced in accordance with the NEWS policy whilst off NIV. 6.33. Observations must be recorded on the NIV Care Plan in addition to the NEWS chart. 6.34. A clinical assessment of mask fit to include skin condition and degree of leak (particularly onto the corneas) should be performed at the same time. 6.35. As a standard ABG should be taken and used to assist in the management plan at 4 hours or earlier if judged clinically necessary and again at 12 hours unless the clinical improvement in the patient obviates the need for further ABG analysis. 6.36. Escalation 6.37. At the initiation of treatment there must be a written plan if NIV fails. This should include whether escalation of care is indicated or whether NIV is the ceiling of treatment and whether the patient is for resuscitation or specific palliative care measures. If the patient is deemed not for resuscitation, an Allow Natural Death Order needs to be completed and communicated to all relevant staffing members in keeping with the AND policy. Page 7 of 17

6.38. Treatment Duration and Weaning from Ventilation 6.39. Treatment duration 6.40. Patients who appear to benefit from NIV during the first few hours of treatment should receive NIV for as long as possible (minimum of 6 hours) with appropriate breaks for oral intake, nebulisers etc, during the first 24 hours. Attention should be paid to skin care on the bridge of the nose during this period. In patients in whom NIV is successful (ph 7.35 achieved, resolution of underlying cause and symptoms, respiratory rate normalised) following an appropriate duration of treatment, it is appropriate to start a weaning plan. Gradual reduction of the duration of NIV should be determined by clinical improvement. 6.41. Weaning 6.42. Initially weaning should be during the day with extended periods off the ventilator for meals, physiotherapy, nebulised therapy etc. Patients may require continued ventilation overnight if stable during the day. Early morning ABGs are required to monitor gas exchange. Most patients should be weaned within 2-3 days. 6.43. Palliation 6.44. Palliation of symptoms is appropriate in patients in whom standard medical treatment and NIV fails or where patients have chosen not to receive this treatment and where a decision has been made and documented not to escalate to intubation and mechanical ventilation. In exceptional circumstances NIV may be continued to palliate breathlessness, but should not be initiated for this reason. Opioids and benzodiazepines can be used to treat breathlessness in this situation. Initiation of palliative care pathways should where possible include appropriate discussion with the patient and family. 6.45. Trouble Shooting 6.46. See appendix 3. 7. Dissemination and Implementation 7.1. This policy will be disseminated throughout all relevant areas in the trust through lead clinicians, ward managers/sisters and managers 7.2. Provision of training is provided by consultant respiratory physicians and the Learning and Development department. Training is mandatory for all staff delivering NIV. 8. Monitoring compliance and effectiveness Element to be monitored Lead Tool Frequency All aspects of the NIV service in keeping with standards set by the British Thoracic Society (see website) Dr Meme Wijesinghe British Thoracic Society (see website) Annually Page 8 of 17

Reporting arrangements Acting on recommendations and Lead(s) Change in practice and lessons to be shared A report is generated annually. This will allow us to benchmark our practice with the rest of the country. Dr Meme Wijesinghe will disseminate audit results If deficiencies are identified, Dr Wijesinghe will identify how changes can be actioned and improvements to the service implemented 9. Updating and Review 9.1. This policy will be reviewed every three years 10. Equality and Diversity 10.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Diversity & Human Rights Policy' or the Equality and Diversity website. 10.2. Equality Impact Assessment 10.3. The Initial Equality Impact Assessment Screening Form is at Appendix 2. 11. References 1. Ram FS, Picot J, Lightowler J, et al. Non-invasive positive pressure ventilation for treatment of respiratory failure due to exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2004;3:CD004104. 2. British Thoracic Society Standards of Care Committee. Non-invasive ventilation in acute respiratory failure. Thorax. 2002;57:192 211. 3. Roberts, C.M.; Brown, J.L.; Reinhardt, A.K.; Kaul, S.; Scales, K.; Mikelsons, C.; Reid, K.; Winter, R.; Young, K.; Restrick, L.; Plant, P.K. Non-invasive ventilation in chronic obstructive pulmonary disease: management of acute type 2 respiratory failure. Clinical Medicine, Journal of the Royal College of Physicians, Volume 8, Number 5, October 2008, pp. 517-521(5) Page 9 of 17

Appendix 1. Governance Information Document Title Date Issued/Approved: 13 Jun 14 Date Valid From: 13 Jun 14 Date Valid To: 13 Jun 17 The Use of Non-Invasive Ventilation in Patients with Acute Type 2 Respiratory Failure Directorate / Department responsible (author/owner): Meme Wijesinghe, Respiratory Medicine Consultant Contact details: 01872 252779 Brief summary of contents The aim of this policy is to provide guidance for all healthcare professionals involved in the delivery of NIV and to ensure that this is done both safely and effectively. Suggested Keywords: Ventilation, Respiratory Failure,. Target Audience Executive Director responsible for Policy: RCHT PCH CFT KCCG Medical Director Date revised: 13 Jun 14 This document replaces (exact title of previous version): Approval route (names of committees)/consultation: Divisional Manager confirming approval processes The Use of Non-Invasive Ventilation in Patients with Acute Type 2 Respiratory Failure Robert Taylor, Consultant in Emergency Medicine Jonathan Paddle, Consultant in Critical Care Audrius Simiatis, Consultant Cardiologist Bruce Daniels Name and Post Title of additional signatories Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Document Library Folder/Sub Folder Links to key external standards Related Documents: Training Need Identified? Not Required {Original Copy Signed} Internet & Intranet Intranet Only Clinical / Respiratory None None No Page 10 of 17

Version Control Table Date Version No 30 Oct 12 V1.0 Initial Issue 13 Jun 14 V2.0 Complete rewrite. Summary of Changes Changes Made by (Name and Job Title) Meme Wijesinghe, Respiratory Medicine Consultant Meme Wijesinghe, Respiratory Medicine Consultant All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager. Page 11 of 17

Appendix 2. Initial Equality Impact Assessment Form Name of the strategy / policy /proposal / service function to be assessed (hereafter referred to as policy) (Provide brief description): The Use of Non-Invasive Ventilation in Patients with Acute Type 2 Respiratory Failure Directorate and service area: Clinical / Is this a new or existing Policy? New Respiratory Name of individual completing Telephone: 01872 252779 assessment: Meme Wijesinghe 1. Policy Aim* Who is the strategy / policy / proposal / service function aimed at? 2. Policy Objectives* See section 2. The aim of this policy is to provide guidance for all healthcare professionals involved in the delivery of NIV and to ensure that this is done both safely and effectively. 3. Policy intended Outcomes* 4. *How will you measure the outcome? 5. Who is intended to benefit from the policy? 6a) Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? See section 6. See section 8. All NIV patients. No b) If yes, have these *groups been consulted? C). Please list any groups who have been consulted about this procedure. 7. The Impact Please complete the following table. Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Rationale for Assessment / Existing Evidence Age Page 12 of 17

Sex (male, female, transgender / gender reassignment) Race / Ethnic communities /groups Disability - Learning disability, physical disability, sensory impairment and mental health problems Religion / other beliefs Marriage and civil partnership Pregnancy and maternity Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian You will need to continue to a full Equality Impact Assessment if the following have been highlighted: You have ticked Yes in any column above and No consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or Major service redesign or development 8. Please indicate if a full equality analysis is recommended. Yes No 9. If you are not recommending a Full Impact assessment please explain why. Signature of policy developer / lead manager / director Date of completion and submission Names and signatures of members carrying out the Screening Assessment 1. Meme Wijesinghe 2. Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust s web site. Signed Date Page 13 of 17

Appendix 3. RCHT care plan and pathway Page 14 of 17

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