Domiciliary application of non-invasive positive pressure ventilation with average volume assured pressure support to subjects with chronic obstructive pulmonary disease (COPD) who remain hypercapnic following the application of non-invasive positive pressure ventilation (NPPV) for an acute exacerbation

ISRCTN	ISRCTN80279999
DOI	https://doi.org/10.1186/ISRCTN80279999
Secondary identifying numbers	EAME06NIV01

Submission date: 15/09/2008
Registration date: 11/12/2008
Last edited: 11/12/2008

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof J L Pepin
Scientific

Laboratoire Exploration Fonctionnelle Cardio-Respiratoire (EFCR)
RDC Haut
CHU Michallon Nord
BP 217
Cedex 09
Grenoble
38043
France

Email	JPepin@chu-grenoble.fr

Study information

Study design	Randomised, parallel group pilot study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	AVAPS-COPD
Study objectives	Long-term domiciliary non-invasive positive pressure ventilation (NPPV) with average volume assured pressure support (AVAPS) in subjects with chronic obstructive pulmonary disease (COPD) who remain hypercapnic following the application of NPPV for an acute exacerbation will improve daytime partial pressure of carbon dioxide (PCO2) and endothelial dysfunction.
Ethics approval(s)	Ethics Committee for Protection of Human Subjects, Grenoble University Hospital (CHU de Grenoble) (ref: CPP08-RESP-1), approval pending as of 11/12/2008.
Health condition(s) or problem(s) studied	Chronic obstructive pulmonary disease (COPD)
Intervention	Treatment group will receive standard optimal care plus NPPV with AVAPS support, ventilatory support function that dynamically determines the pressure support level, which generates the target or control level of exhaled tidal volume by producing a gradual pressure change based on the preceding several breaths. Control group will receive standard optimised care. Total duration of interventions/follow-up: 1 year
Intervention type	Other
Primary outcome measure	1. Daytime PCO2, measured by arterial blood gases at baseline, 1, 3, 6 months and 1 year 2. Endothelial dysfunction, measured by peripheral arterial tone (PAT) at baseline, 1, 3, 6 months and 1 year
Secondary outcome measures	1. Lung function, measured by spirometry, according to the joint recommendations of the ERS/ATS. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year 2. Dyspnoea, measured at rest by the Borg scale. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year. 3. Fatigue, measured by Fatigue Severity Scale (FSS). The FSS questionnaires contains nine statements that rate the severity of the subject's fatigue symptoms an a scale from 1 to 7. A total score of less than 36 suggests that the subject may not be suffering from fatigue, while a score of greater than or equal to 36 indicates excessive fatigue. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year. 4. Sleep quality, measured by polysomnography (PSG), including transcutaneous PCO2. At baseline, PSG will be performed in spontaneous breathing in order to characterise the abnormal respiratory events associated with COPD and identify obstructive sleep apnoea (OSA). Sleep and respiratory events will be recorded and scored manually according to standard criteria. REM hypoventilation will be scored when a progressive oxygen desaturation is associated with a sustained reduction in both flow and thoracic components of ventilation. During the same period, a constant or reduced respiratory drive (assessed by a reduction in respiratory effort as demonstrated by pulse transit time) should be observed without characteristic apnoeic or hypopnoeic episodes. At 3 months and 1 year, polysomnography will be done in spontaneous breathing or using non-invasive ventilation depending the arm of the study. Timepoints of assessment: baseline, 3 months and 1 year. 5. Objective sleepiness as measured by the Osler Test. This test consists of a 40 minutes sleep-resistance challenge conducted in a dark and quiet room. The subject will be asked to remain awake while reacting to a visual stimulus, which appears for 1 second every 3 seconds, by hitting a button. Sleep latency will be defined as the delay between the onset of the test and the moment corresponding to seven consecutive flashes (i.e. 21 seconds) without response. Fluctuations in vigilance and micro-sleep episodes will be quantified as the number of occasions that 3 to 6 consecutive flashes occur without response (i.e. 9 to 18 seconds without response of the patient). Timepoints of assessment: baseline, 1, 3, 6 months and 1 year. 6. Exercise capacity. At baseline a practice test will be performed at least one hour before the actual test. The highest 6-minute walk distance will be reported as the patient's 6-minute walk distance at baseline. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year. 7. Physical activity. This will be objectively measured using the Actiwatch®. The Actiwatch® measures activity with a piezo-electric accelerometer that records intensity, amount and duration of movement in all directions. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year. 8. Quality of life, measured using the validated French version of the St Georges Respiratory Questionnaire. Timepoints of assessment: baseline, 1, 3, 6 months and 1 year. 9. Arterial stiffness, determined by pulse wave velocity (PWV). Timepoints of assessment: baseline, 1, 3, 6 months and 1 year. 10. Time in hospital over course of follow up period
Overall study start date	01/11/2008
Completion date	01/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Key inclusion criteria	1. Both males and females, aged 50 - 80 years 2. Confirmed diagnosis of COPD according to the joint recommendations of the European Respiratory Society/American Thoracic Society (ERS/ATS) 3. Minimum of 48 hours without NPPV after using NPPV or invasive ventilation in hospital during an acute exacerbation of COPD 4. Persistent hypercapnia (partial pressure of carbon dioxide in the arterial blood [PaCO2] greater than or equal to 50 mmHg, but less than 65 mmHg with an arterial pH above 7.32) during room air spontaneous breathing 5. Able to follow instructions 6. Able to provide informed consent
Key exclusion criteria	1. Actively smoking 2. Therapy with systemic steroids 3. Important concomitant chronic systemic diseases (i.e. chronic heart failure [left ventricular ejection fraction less than 45%], diabetes, infections, neoplasm, forms of sleep disordered breathing, etc) 4. Other chronic respiratory diseases (e.g., significant fibrothorax, bronchiectasis, cystic fibrosis)
Date of first enrolment	01/11/2008
Date of final enrolment	01/11/2010

Locations

Countries of recruitment

France

Study participating centre

Laboratoire Exploration Fonctionnelle Cardio-Respiratoire (EFCR)

Grenoble
38043
France

Sponsor information

Respironics International, Inc. (France)
Industry

20 Rue-Jacques Daguerre
Rueil-Malmaison
Paris
92500
France

Email	steven.coughlin@respironics.com
Website	http://www.respironics.com
"ROR"	https://ror.org/05jz46060

Funders

Funder type

Industry

Respironics International, Inc. (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan