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NCT00189527 Clinical Trial

Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation in Chronic Respiratory Failure

Chronic Respiratory Failure Clinical Trial

Official title:
Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00189527
Other study ID # 2000-2
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated February 16, 2011
Start date January 2006
Est. completion date October 2009

Study information
Verified date February 2011
Source Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

Noninvasive ventilation is a therapeutic option in some patients with chronic respiratory failure. Patients usually ventilate during nightime with a domiciliary ventilator either in assist control or in pressure support mode.

The aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.

Description:

The aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date October 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Chronic respiratory failure

- Clinical symptoms of chronic alveolar hypoventilation

- PaCO2 = 45 mmHg in case of restrictive pulmonary disorder or PaCO2 = 55 mmHg in case or obstructive pulmonary disorder

Exclusion Criteria:

- Clinical exacerbation during the three previous weeks

- Previous treatment by domiciliary non invasive ventilation

- Previous treatment by non invasive ventilation for acute respiratory failure during the 3 previous months

- Bronchiectasis

- Duchenne muscular dystrophy

- Amyotrophic lateral sclerosis

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• respiratory settings

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Outcome
Type Measure Description Time frame Safety issue
Primary PaO2 Blood gases response to ventilation months No
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