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

Overlap Syndrome Clinical Trial

— OVNI-Dom  

Official title:

Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome: Randomized Controlled Non-inferiority Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02363413
• Other study ID #: VNI_001
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2015
• Last updated: August 5, 2015
• Start date: February 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2015
• Source: IP Santé Domicile
• Contact: Géraldine Boy, PhD
• Phone: 0607434961
• Email: geraldine.boy[@]ipsante.com
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Overlap Syndrome
• Syndrome

Intervention

Other:
• IniVAH
Initiation of the NIV during a 3 days hospitalization as usual.
• 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.

Locations

Country	Name	City	State
France	CH Annecy-Genevois	Annecy
France	Clinique Chirurgicale Bel-Air	Bordeaux
France	CH Cannes	Cannes
France	CHU Dijon	Dijon
France	CH Intercommunal du Val d'Ariège	Foix
France	Hôpital Raymond Poincaré	Garches
France	CHU de Grenoble site Nord - Hôpital Albert Michallon	Grenoble
France	Centre Hospitalier Haguenau	Haguenau
France	Clinique Du Blanc Mesnil	le Blanc Mesnil
France	Clinique Mutualiste du Medoc	Lesparre
France	CHR - Hôpital Calmette	Lille
France	CHU Bichat - Claude Bernard	Paris
France	CHU La Pitié-salpétrière	Paris
France	Clinique Saint Laurent	Rennes
France	Institut Arnault Tzanck	Saint Laurent du Var
France	CHU de Strasbourg - Hôpital Civil	Strasbourg
France	Hôpital Larrey CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
IP Santé Domicile

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compliance- average adherence measured over the three months under NIV expressed in hours/night		month 3 (M3)	No
Secondary	quality of ventilation : evolution of the pCO2 and nocturnal saturation at M3		month 3 (M3)	No
Secondary	quality of life and satisfaction of the patients : patient life satisfaction questionnaire		month 3 (M3)	No
Secondary	the occurrence of complications : number of NIV complication occurred		month 3	No
Secondary	economic study- number of hospitalization nights		month 3 (M3)	No
Secondary	economic study- number of intervention of the kinesiologist and the technician		month 3 (M3)	No
Secondary	economic study- number of phone contact by the patient		month 3 (M3)	No