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

NCT02363413 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-08-06

No results posted yet for this study

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

Interventions

OTHER

IniVAH

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

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.

Sponsors & Collaborators

  • IP Santé Domicile

    lead INDUSTRY

Principal Investigators

  • Safia Maaradji-Gati, MD · IPSanté Domicile

  • Jésus Gonzalez, MD · La Pitié-Salpétrière

  • Marie Pia D'orthor, MD · Hôpital Bichat - Claude Bernard

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02363413 on ClinicalTrials.gov