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

This study has been completed.
Sponsor:
Information provided by:
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier:
NCT00189527
First received: September 12, 2005
Last updated: February 16, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention
Chronic Respiratory Failure
 Procedure: respiratory settings

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:

Primary Outcome Measures:
  • PaO2 [ Time Frame: months ] [ Designated as safety issue: No ]
    Blood gases response to ventilation


Enrollment: 100
Study Start Date: January 2006
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189527

Sponsors and Collaborators
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Investigators
Principal Investigator: Antoine CUVELIER, MD, PhD Rouen University Hospital
  More Information

No publications provided

Responsible Party: Pr A Cuvelier, CHU Rouen
ClinicalTrials.gov Identifier: NCT00189527     History of Changes
Other Study ID Numbers: 2000-2
Study First Received: September 12, 2005
Last Updated: February 16, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013