Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome

NCT ID: NCT02363413

Last Updated: 2015-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-03-31

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.

Conditions

Overlap Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

IniVAH

Initiation of the NIV in hospital : current care. 3 days hospitalization to start-up the NIV as usual.

Group Type: ACTIVE_COMPARATOR

IniVAH

Intervention Type: OTHER

Initiation of the NIV during a 3 days hospitalization as usual.

IniVAD

Initiation of the NIV at home : experimental care.

Group Type: EXPERIMENTAL

IniVAD

Intervention Type: OTHER

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.

Interventions

IniVAH

Initiation of the NIV during a 3 days hospitalization as usual.

Intervention Type: OTHER

IniVAD

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.

Intervention Type: OTHER

Other Intervention Names

Initiation of the NIV at hospital : current care; Initiation of the NIV at home

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IP Santé Domicile

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Safia Maaradji-Gati, MD

Role: STUDY_DIRECTOR

IPSanté Domicile

Jésus Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

La Pitié-Salpétrière

Marie Pia D'orthor, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bichat - Claude Bernard

Locations

CH Annecy-Genevois

Annecy, , France

Site Status: NOT_YET_RECRUITING

Clinique Chirurgicale Bel-Air

Bordeaux, , France

Site Status: RECRUITING

CH Cannes

Cannes, , France

Site Status: NOT_YET_RECRUITING

CHU Dijon

Dijon, , France

Site Status: NOT_YET_RECRUITING

CH Intercommunal du Val d'Ariège

Foix, , France

Site Status: NOT_YET_RECRUITING

Hôpital Raymond Poincaré

Garches, , France

Site Status: NOT_YET_RECRUITING

CHU de Grenoble site Nord - Hôpital Albert Michallon

Grenoble, , France

Site Status: NOT_YET_RECRUITING

Centre Hospitalier Haguenau

Haguenau, , France

Site Status: NOT_YET_RECRUITING

Clinique Du Blanc Mesnil

Le Blanc-Mesnil, , France

Site Status: RECRUITING

Clinique Mutualiste du Medoc

Lesparre-Médoc, , France

Site Status: NOT_YET_RECRUITING

CHR - Hôpital Calmette

Lille, , France

Site Status: NOT_YET_RECRUITING

CHU Bichat - Claude Bernard

Paris, , France

Site Status: RECRUITING

CHU La Pitié-salpétrière

Paris, , France

Site Status: NOT_YET_RECRUITING

Clinique Saint Laurent

Rennes, , France

Site Status: RECRUITING

Institut Arnault Tzanck

Saint-Laurent-du-Var, , France

Site Status: NOT_YET_RECRUITING

CHU de Strasbourg - Hôpital Civil

Strasbourg, , France

Site Status: NOT_YET_RECRUITING

Hôpital Larrey CHU Toulouse

Toulouse, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Géraldine Boy, PhD

Role: CONTACT

geraldine.boy@ipsante.com

0607434961

Safia Maaradji-Gati, MD

Role: CONTACT

safia.maaradji-Gati@ipsante.com

0674038420

Facility Contacts

Taoufik DIDI, MD

Role: primary

tdidi@ch-annecygenevois.fr

04 50 63 66 03

Nathalie RAYMOND, MD

Role: primary

drraymond.nathalie@orange.fr

05 56 73 11 64

Christophe PERRIN, MD

Role: primary

C.PERRIN@ch-cannes.fr

06 79 57 51 33

Claudio RABEC, MD

Role: primary

claudio.rabec@chu-dijon.fr

06 62 28 11 92

Abdelkader GHAZI, MD

Role: primary

abdelkader.ghazi@chi-val-ariege.fr

05 61 03 31 30

David ORLIKOWSKI, MD

Role: primary

david.orlikowski@aphp.fr

01 47 10 77 52

Jean-louis PEPIN, MD

Role: primary

JPepin@chu-grenoble.fr

04 76 76 92 65

Parisa ASSEMI, MD

Role: primary

03 88 06 33 33

Naim FOURAR, MD

Role: primary

naimfourar@hotmail.fr

06 50 60 16 69

Nathalie RAYMOND, MD

Role: primary

drraymond.nathalie@orange.fr

05 56 73 11 64

Stéphanie FRY, MD

Role: primary

Stephanie.POUWELS@CHRU-LILLE.FR

03 20 44 5948

Marie Pia d'ORTHO, MD

Role: primary

marie-pia.dortho@bch.aphp.fr

01 40 25 84 01

Jésus GONZALEZ, MD

Role: primary

jesus.gonzalez@psl.aphp.fr

06 65 63 59 36

Arnaud PRIGENT, MD

Role: primary

prigent@icloud.com

02 99 38 33 69

Guy-René BOYER, MD

Role: primary

guyboyer@wanadoo.fr

04 92 27 38 72

Romain KESSLER, MD

Role: primary

romain.kessler@chru-strasbourg.fr

06 60 27 48 90

Kamila SEDKAOUI, MD

Role: primary

sedkaoui.k@chu-toulouse.fr

05 67 77 18 32

Other Identifiers

VNI_001

Identifier Type: -

Identifier Source: org_study_id