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

• Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche (Other)
• Overall Status: Completed
• CT.gov ID: NCT00189527
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Duration (Months): 45

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Respiratory Failure	Procedure: respiratory settings	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: respiratory support a mode of ventilation in comparison	Procedure: respiratory settings
Active Comparator: Assist Control an other mode of ventilation in comparison	Procedure: respiratory settings

Outcome Measures

Primary Outcome Measures

1. PaO2 [months]

   Blood gases response to ventilation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Investigators

• Principal Investigator: Antoine CUVELIER, MD, PhD, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00189527
• Other Study ID Numbers: 2000-2
• First Posted: Sep 19, 2005
• Last Update Posted: Feb 17, 2011
• Last Verified: Feb 1, 2011

• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

No Results Posted as of Feb 17, 2011