The study is based on the assumption that in the Overlap Syndrome, the introduction at home of the NIV is as effective in terms of compliance and clinical and gazometric improvement, and life quality, that setting hospital start up. The investigators will study the initiation of NIV at home versus in hospital in two randomized Overlap Syndrome patient groups. The main objective of the study is to demonstrate the non-inferiority of the initiation of the NIV at home versus hospital in terms of compliance.
The Overlap Syndrome is defined by the coexistence of chronic obstructive pulmonary disease (COPD) and an apnea - hypopnea syndrome obstructive sleep (SAHS). The interaction between these two diseases is responsible for deepest nocturnal desaturation, decreased sensitivity to CO2, more pronounced sleep alterations, more frequent daytime hypercapnia, a higher risk of hypertension pulmonary and increased cardiovascular risk, compared to subjects with COPD or isolated SAHS. The Overlap Syndrome treatments are continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV), associated complemented or not by oxygen therapy during sleep. The criteria for choosing the type of treatment are not well defined. Quality and compliance of the NIV are very important in all diseases leading to chronic respiratory failure whose Overlap Syndrome. The increase in the number of patients treated with NIV is estimated at over 12% per year. The NIV startup is usually performed in a conventional hospitalization but congestion healthcare pathways lead to increase waiting time before treatment. Thus, to date, no study has validated a supported alternative to meet the increase in the number of patients on NIV while maintaining quality service. The HAS has defined good candidates for a NIV home based startup, on the following criteria: patients with a recognized indication of NIV in the long term , with stable respiratory failure, requiring only nocturnal ventilation, surrounded by caregivers mastering the use of equipment and whose location allows rapid intervention. The study is based on the assumption that in the Overlap Syndrome, the introduction at home of the NIV is as effective in terms of compliance and clinical and gazometric improvement, and life quality, that setting hospital start up. The investigators will study the initiation of NIV at home versus in hospital in two randomized Overlap Syndrome patient groups. The main objective of the study is to demonstrate the non-inferiority of the initiation of the NIV at home versus hospital in terms of compliance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
Initiation of the NIV during a 3 days hospitalization as usual.
Initiation of the NIV at home. The first day, the kinesiologist and the technician start-up the NIV at home with the patient. The investigator will validate the adjustment settings proposed by the kinesiologist. No procedure during the second day as described by the HAS. The third day, the kinesiologist and the technician come back to the patient home so as to adjust the settings if needed and if validated by the investigator.
CH Annecy-Genevois
Annecy, France
NOT_YET_RECRUITINGClinique Chirurgicale Bel-Air
Bordeaux, France
compliance- average adherence measured over the three months under NIV expressed in hours/night
Time frame: month 3 (M3)
quality of ventilation : evolution of the pCO2 and nocturnal saturation at M3
Time frame: month 3 (M3)
quality of life and satisfaction of the patients : patient life satisfaction questionnaire
Time frame: month 3 (M3)
the occurrence of complications : number of NIV complication occurred
Time frame: month 3
economic study- number of hospitalization nights
Time frame: month 3 (M3)
economic study- number of intervention of the kinesiologist and the technician
Time frame: month 3 (M3)
economic study- number of phone contact by the patient
Time frame: month 3 (M3)
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