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

ISRCTN	ISRCTN00075564
DOI	https://doi.org/10.1186/ISRCTN00075564
Protocol serial number	04/Q0104/139 - NRR Publication ID: N0542155456
Sponsor	Papworth Hospital NHS Trust (UK)
Funder	Respiratory Support and Sleep Centre Trust fund supported by an unrestricted grant from B & D Electromedical (UK)

Submission date: 23/05/2005
Registration date: 08/07/2005
Last edited: 16/07/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nick Oscroft
Scientific

Papworth Hospital NHS Trust
Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Phone	+44 (0)1480 830541

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Currently it is unclear whether patients with severe COPD benefit from noninvasive positive pressure ventilation in the long term. There is divided opinion and evidence on whether this is a beneficial treatment and who might benefit. In performing this clinical trial of withdrawal of a non-proven treatment with close monitoring we plan to address the issue of whether of not the treatment does maintain the patients in a stable clinical state and improve their quality of life.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic Obstructive Pulmonary Disease (COPD)
Intervention	Comparison of withdrawing long term NIPPV treatment or continuing
Intervention type	Other
Primary outcome measure(s)	'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
Key secondary outcome measure(s)	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
Completion date	31/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key 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
Key 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)
Date of first enrolment	16/05/2005
Date of final enrolment	31/01/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Papworth Hospital NHS Trust

Cambridge
CB3 8RE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010		Yes	No