NCT00189527

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2011

Enrollment Period

3.4 years

First QC Date

September 12, 2005

Last Update Submit

February 16, 2011

Conditions

Chronic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • PaO2

    Blood gases response to ventilation

    months

Study Arms (2)

respiratory support

EXPERIMENTAL

a mode of ventilation in comparison

Procedure: respiratory settings

Assist Control

ACTIVE COMPARATOR

an other mode of ventilation in comparison

Procedure: respiratory settings

Interventions

respiratory settingsPROCEDURE
Assist Controlrespiratory support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Antoine CUVELIER, MD, PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

January 1, 2006

Primary Completion

June 1, 2009

Study Completion

October 1, 2009

Last Updated

February 17, 2011

Record last verified: 2011-02