Comparing standard and accelerated weaning from non-invasive breathing support in exacerbation of chronic obstructive pulmonary disease

Not Applicable

• Conditions: Exacerbation of chronic obstructive pulmonary disease (COPD); Respiratory; Other chronic obstructive pulmonary disease

• Registration Number: ISRCTN64639614
• Lead Sponsor: orthumbria Healthcare NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-14
• Last Update Posted: 15 January 2024
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

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)

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to successful weaning: duration from the baseline arterial blood gas confirming selection criteria met, to final removal of the ventilator. Death on NIV precludes weaning and will be captured in a competing risk analysis.