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

NCT02363413 | Unknown

• 1 other identifier: VNI_001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 17

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.

Conditions

Overlap Syndrome

Keywords

NIV; Overlap Syndrom; home; hospital

Outcome Measures

Primary Outcomes (1)

• compliance- average adherence measured over the three months under NIV expressed in hours/night

  month 3 (M3)

Secondary Outcomes (6)

• quality of ventilation : evolution of the pCO2 and nocturnal saturation at M3

  month 3 (M3)

• quality of life and satisfaction of the patients : patient life satisfaction questionnaire

  month 3 (M3)

• the occurrence of complications : number of NIV complication occurred

  month 3

• economic study- number of hospitalization nights

  month 3 (M3)

• economic study- number of intervention of the kinesiologist and the technician

  month 3 (M3)

Study Arms (2)

IniVAH

ACTIVE COMPARATOR

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

Other: IniVAH

IniVAD

EXPERIMENTAL

Initiation of the NIV at home : experimental care.

Other: IniVAD

Interventions

IniVAH OTHER

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

Also known as: Initiation of the NIV at hospital : current care

IniVAH

IniVAD 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.

Also known as: Initiation of the NIV at home

IniVAD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IP Santé Domicile: lead

Study Sites (17)

CH Annecy-Genevois

Annecy, 74374, France

NOT YET RECRUITING

Clinique Chirurgicale Bel-Air

Bordeaux, 33073, France

RECRUITING

CH Cannes

Cannes, 06401, France

NOT YET RECRUITING

CHU Dijon

Dijon, 21000, France

NOT YET RECRUITING

CH Intercommunal du Val d'Ariège

Foix, 09017, France

NOT YET RECRUITING

Hôpital Raymond Poincaré

Garches, 92380, France

NOT YET RECRUITING

CHU de Grenoble site Nord - Hôpital Albert Michallon

Grenoble, 38043, France

NOT YET RECRUITING

Centre Hospitalier Haguenau

Haguenau, 67500, France

NOT YET RECRUITING

Clinique Du Blanc Mesnil

Le Blanc-Mesnil, 93150, France

RECRUITING

Clinique Mutualiste du Medoc

Lesparre-Médoc, 33340, France

NOT YET RECRUITING

CHR - Hôpital Calmette

Lille, 59037, France

NOT YET RECRUITING

CHU Bichat - Claude Bernard

Paris, 75018, France

RECRUITING

CHU La Pitié-salpétrière

Paris, 75651, France

NOT YET RECRUITING

Clinique Saint Laurent

Rennes, 35700, France

RECRUITING

Institut Arnault Tzanck

Saint-Laurent-du-Var, 06721, France

NOT YET RECRUITING

CHU de Strasbourg - Hôpital Civil

Strasbourg, 67091, France

NOT YET RECRUITING

Hôpital Larrey CHU Toulouse

Toulouse, 31053, France

NOT YET RECRUITING

Study Officials

• Safia Maaradji-Gati, MD

  IPSanté Domicile

  STUDY DIRECTOR

• Jésus Gonzalez, MD

  La Pitié-Salpétrière

  PRINCIPAL INVESTIGATOR

• Marie Pia D'orthor, MD

  Hôpital Bichat - Claude Bernard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Géraldine Boy, PhD

CONTACT

0607434961; geraldine.boy@ipsante.com

Safia Maaradji-Gati, MD

CONTACT

0674038420; safia.maaradji-Gati@ipsante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 16, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

FR (17)