Standard versus accelerated weaning from non-invasive ventilation (NIV) in chronic obstructive pulmonary disease directed by the NIV outcomes score: a randomised controlled trial
Exacerbation of chronic obstructive pulmonary disease (COPD)
Patients with exacerbation of COPD requiring NIV who have low or medium risk NIV outcomes scores will be assessed against the full selection criteria detailed below. Consenting patients who meet the eligibility criteria will be independently randomised on a 1:1 basis between the two treatment strategies, performed independently (sealedenvelope.com) using minimisation to ensure groups are balanced for: a) NIV Outcomes score: low or medium risk; b) Site; c) HCO₃-: <28 or ≥28; d) pH: <7.18 or ≥7.18; e) previous NIV: yes or no. Standard weaning protocol: Progressively longer periods off NIV, determined by arterial blood gas (or capillary blood gas), with a final night on NIV after a full day off NIV. Accelerated weaning protocol: Daily 4-hour weaning trial, success confirmed by arterial blood gas, with additional transcutaneous carbon dioxide monitoring. The weaning time endpoint is the date and time that the NIV mask is removed from the patient’s face for the final time (provided NIV does not need to be recommenced within 48 hours).
1. Clinical diagnosis of Exacerbation of Chronic Obstructive Pulmonary Disease, complicated by acute hypercapnic respiratory failure (pH <7.35 and PaCO₂ >6.5 kPa) 2. Age 35 years or over 3. Smoking history of 10 or more pack years 4. Low or medium risk Non-Invasive Ventilation (NIV) Outcomes score 5. Provision of acute NIV for 24 hours or longer 6. Correction of respiratory acidaemia 7. PaCO₂ <8 kPa, or PaCO₂ 8-9 kPa with at least a 20% fall in PaCO₂ from pre-NIV baseline value 8. Able to tolerate 60 minutes of unsupported breathing, confirmed by arterial blood gas (ABG) 9. Participants must be randomised within 24 hours of meeting the weaning criteria (based on the time of the qualifying ABG)
1. Poor tolerance of NIV likely to limit adherence to protocol 2. Receiving home ventilation on admission, or planned referral for home ventilation on discharge 3. Inability to provide informed consent 4. Failure of another organ requiring level 2 or 3 organ support 5. Clinically significant pulmonary fibrosis 6. Metastatic cancer, advanced haematological malignancy, or other serious comorbidities, which may influence survival or decisions about ventilation within the time frame of the trial (3 months)