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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Respiratory assistance by a facial mask without intubation or tracheotomy
Long term oxygenatory tyherapy without NIV
University Hospital Grenoble
La Tronche, France
Nocturnal transcutaneous pressure CO2 (PtCO2)
Measurement of nocturnal PtCO2 using the SenTec system
Time frame: 3 months
Saint George's Respiratory Questionnaire
Measure of quality of life
Time frame: 3 months
FEV1
Pulmonary function tests
Time frame: 3 months
Vital capacity
Pulmonary function tests
Time frame: 3 months
PaO2
Blood gases
Time frame: 3 months
PaCO2
Blood gases
Time frame: 3 months
Steps per day
Physical activity measured at home (one week)
Time frame: 3 months
Time in supine and sitting positions
Physical activity measured at home (one week)
Time frame: 3 months
Energy expenditure
Physical activity measured at home (one week)
Time frame: 3 months
Heart Rate
Physiological responses during the Semi paced 3-min Chair rise test
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Time frame: 3 months
SaO2
Physiological responses during the Semi paced 3-min Chair rise test
Time frame: 3 months
Dyspnea score
Symptoms during the Semi paced 3-min Chair rise test
Time frame: 3 months
Fatigue score
Symptoms during the Semi paced 3-min Chair rise test
Time frame: 3 months
Cholesterol
Biological parameters
Time frame: 3 months
Triglycerides
Biological parameters
Time frame: 3 months
Fasting Glucose
Biological parameters
Time frame: 3 months
CRPus
Biological parameters
Time frame: 3 months
HBA1c
Biological parameters
Time frame: 3 months