Clinical trial NCT02363413: Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome
Official title: Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome: Randomized Controlled Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overlap Syndrome
Keywords: NIV
Overlap Syndrom
home
hospital
Lead sponsor: IP Santé Domicile
Sponsor class: INDUSTRY
First posted: 2015-02-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Major patients, of less than 80 years
* Patients with chronic respiratory failure within a Overlap syndrome ( defined by the coexistence of COPD and OAS ) in stable situation (no exacerbation for at least 4 weeks) , indication for a NIV treatment
* OAS confirmed by polysomnography according to the standards of the American Academy of Sleep Medicine ( AASM ) with an AHI\> 15, the central apneas are tolerated if \< 20%
* COPD defined by obstruction of the air flow : VEMS/CVF \<70 % and VEMS \<80% of the average value predicted
* Started criteria of NIV: chronic respiratory failure within an Overlap Syndrome and PaCO2 \> 45 mmHg (at rest on room air ) and / or medium PtCO2 \> 50 mmHg
* Patient informed of the study and who signed an informed consent

Exclusion Criteria:

* Patients already treated for OAS in the year
* Patient tracheotomised
* Other diseases with respiratory involvement : neuromuscular disease , restrictive disease of the chest with CPT \<80% , apnea syndrome pure central sleep ( central apnea are tolerated if \< 20% )
* Lung cancer within the last 5 years
* Uncontrolled psychic diseases
* Acute respiratory failure requiring NIV , going back a month
* Clinical situation requiring prolonged hospitalization
* Patients with no opportunity to understand and follow instructions
* Refusal to participate in the study
* Lack of insurance coverage
* Pregnant and / or nursing

Primary outcomes:
measure: compliance- average adherence measured over the three months under NIV expressed in hours/night
timeFrame: month 3 (M3)
Secondary outcomes:
measure: quality of ventilation : evolution of the pCO2 and nocturnal saturation at M3
timeFrame: month 3 (M3)
measure: quality of life and satisfaction of the patients : patient life satisfaction questionnaire
timeFrame: month 3 (M3)
measure: the occurrence of complications : number of NIV complication occurred
timeFrame: month 3
measure: economic study- number of hospitalization nights
timeFrame: month 3 (M3)
measure: economic study- number of intervention of the kinesiologist and the technician
timeFrame: month 3 (M3)
measure: economic study- number of phone contact by the patient
timeFrame: month 3 (M3)
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH Annecy-Genevois
city: Bordeaux
country: France
facility: Clinique Chirurgicale Bel-Air
city: Cannes
country: France
facility: CH Cannes
city: Dijon
country: France
facility: CHU Dijon
city: Foix
country: France
facility: CH Intercommunal du Val d'Ariège
city: Garches
country: France
facility: Hôpital Raymond Poincaré
city: Grenoble
country: France
facility: CHU de Grenoble site Nord - Hôpital Albert Michallon
city: Haguenau
country: France
facility: Centre Hospitalier Haguenau
city: le Blanc Mesnil
country: France
facility: Clinique Du Blanc Mesnil
city: Lesparre
country: France
facility: Clinique Mutualiste du Medoc
city: Lille
country: France
facility: CHR - Hôpital Calmette
city: Paris
country: France
facility: CHU Bichat - Claude Bernard
city: Paris
country: France
facility: CHU La Pitié-salpétrière
city: Rennes
country: France
facility: Clinique Saint Laurent
city: Saint Laurent du Var
country: France
facility: Institut Arnault Tzanck
city: Strasbourg
country: France
facility: CHU de Strasbourg - Hôpital Civil
city: Toulouse
country: France
facility: Hôpital Larrey CHU Toulouse
Study officials:
affiliation: IPSanté Domicile
name: Safia Maaradji-Gati, MD
role: STUDY_DIRECTOR
affiliation: La Pitié-Salpétrière
name: Jésus Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Bichat - Claude Bernard
name: Marie Pia D'orthor, MD
role: PRINCIPAL_INVESTIGATOR
References: