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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN00075564

Enrollment

Registered

2005-07-08

Start date

2005-05-16

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Respiratory Chronic obstructive pulmonary disease (COPD)

Interventions

Comparison of withdrawing long term NIPPV treatment or continuing

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pre-screening criteria: 1. Diagnosis of COPD: forced expiratory volume in 1 second (FEV1) 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

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)

Design outcomes

Primary

Measure	Time frame
'Withdrawal Failure' as stipulated by preset criteria. The effect of withdrawal of NIPPV therapy on arterial blood gas analysis. Criteria for Withdrawal Failure: 1. Daytime PaCO2 >9 kPa 2. Nocturnal PtcCO2 >10 on night study 3. Respiratory acidosis pH <7.35 4. Intolerable symptoms, including morning headache and drowsiness	—

Secondary

Measure	Time frame
1. Assess the effect of withdrawal of NIPPV therapy on: quality of life using SF-36 and St George's respiratory questionnaire, exacerbation rates, hospital admissions, GP contact and requirements for treatment with antibiotics and steroids 2. Assess that if preset criteria are met, reinstitution of NIPPV therapy has positive effects 3. Measure changes to spirometric, mouth pressure data and exercise capacity	—

Measure

Time frame

1. Assess the effect of withdrawal of NIPPV therapy on: quality of life using SF-36 and St George's respiratory questionnaire, exacerbation rates, hospital admissions, GP contact and requirements for treatment with antibiotics and steroids 2. Assess that if preset criteria are met, reinstitution of NIPPV therapy has positive effects 3. Measure changes to spirometric, mouth pressure data and exercise capacity

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026