Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Oxygenation Long term, Non invasive Ventilation, Nocturnal Hypoventilation
Brief summary
The aim of this study is to investigate the efficacy of non-invasive ventilation (NIV) on nocturnal hypoventilation in patients with chronic obstructive pulmonary disease (COPD) who are on long term oxygen therapy (LTOT) at home.
Detailed description
This is a prospective, randomized, open labelled study. The primary outcome is nocturnal transcutaneous CO2 (PtCO2) after 3 months of non-invasive ventilation. Three hundred COPD patients on LTOT will be screened and assessed by pulmonary function tests, blood gases and nocturnal PtCO2 at their home. This will allow the determination of the prevalence of nocturnal hypoventilation in COPD patients on LTOT (a secondary outcome) and to select patients who meet the inclusion criteria for the RCT and randomization to NIV + LTOT or to continue LTOT alone (n=38). Patients will undergo the same assessments at the end of the three-month intervention period.
Interventions
DEVICENIV Device + LTOT
Respiratory assistance by a facial mask without intubation or tracheotomy
DEVICELTOT
Long term oxygenatory tyherapy without NIV
Sponsors
AGIR à Dom
ResMed
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* chronic obstructive pulmonary disease (COPD) * on long term oxygen therapy (LTOT) * affiliated to French social security system or equivalent * informed consent signed
Exclusion criteria
* Diurnal PtCO2 \>55mmHg * Patient who has had an exacerbation of COPD requiring a change in management or treatment in the last 4 weeks prior to the inclusion visit. * Pregnant or breathfeeding women * Prisonners or persons who require protection by the law * Exclusion period from another study * Persons who, according to the investigator, are expected no to meet all study obligations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal transcutaneous pressure CO2 (PtCO2) | 3 months | Measurement of nocturnal PtCO2 using the SenTec system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 | 3 months | Pulmonary function tests |
| Vital capacity | 3 months | Pulmonary function tests |
| PaO2 | 3 months | Blood gases |
| PaCO2 | 3 months | Blood gases |
| Steps per day | 3 months | Physical activity measured at home (one week) |
| Time in supine and sitting positions | 3 months | Physical activity measured at home (one week) |
| Energy expenditure | 3 months | Physical activity measured at home (one week) |
| Heart Rate | 3 months | Physiological responses during the Semi paced 3-min Chair rise test |
| Saint George's Respiratory Questionnaire | 3 months | Measure of quality of life |
| Dyspnea score | 3 months | Symptoms during the Semi paced 3-min Chair rise test |
| Fatigue score | 3 months | Symptoms during the Semi paced 3-min Chair rise test |
| Cholesterol | 3 months | Biological parameters |
| Triglycerides | 3 months | Biological parameters |
| Fasting Glucose | 3 months | Biological parameters |
| CRPus | 3 months | Biological parameters |
| HBA1c | 3 months | Biological parameters |
| SaO2 | 3 months | Physiological responses during the Semi paced 3-min Chair rise test |
Countries
France
Outcome results
None listed