A trial of withdrawal of nocturnal non-invasive positive pressure ventilation (NIPPV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic ventilatory failure previously stable on nocturnal NIPPV

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Respiratory; Chronic obstructive pulmonary disease (COPD)

• Registration Number: ISRCTN00075564
• Lead Sponsor: Papworth Hospital NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Pre-screening criteria:
1. Diagnosis of COPD: forced expiratory volume in 1 second (FEV1) <50% predicted, FEV1/forced vital capacity (FVC) ratio <70%, total lung capacity (TLC) >80% predicted
2. Smoking history >20 pack years
3. Prior to commencing NIPPV hypercapnic ventilatory failure with daytime PaCO2 >7.5 kPa with normal pH (7.35-7.45) or nocturnal PtcCO2 >9 kPa
4. On NIPPV for at least 3 months with compliance of >4 hours/day
5. Live within 40-mile radius of trust

Screening criteria:
1. Clinically stable - no increase in breathlessness, cough or sputum volume in 4 weeks between initial assessment and entry to trial
2. PaCO2 within +/-1 kPa of initial assessment
3. No change in spirometry (<15% or 200 ml) from initial assessment

Exclusion Criteria

1. Age over 80
2. Other significant respiratory disease (interstitial lung disease, asthma, bronchiectasis, neuromuscular or restrictive chest wall disorders)
3. Significant documented left ventricular dysfunction with Ejection Fraction <40%
4. Obstructive sleep apnoea with an apnoea/hypopnoea index of over 10, which is reversible by continuous positive airway pressure (CPAP)

Study & Design

• Study Type: Interventional
• Study Design: Not specified