NCT00213395

Brief Summary

Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are determinant to get an optimal NIV efficacy in parallel with ventilatory comfort. Facial masks during NIV are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. In order to limit these side effects, a cephalic interface has been recently designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. However, this mask has a high volume that may interfere with NIV efficacy and may also induce claustrophobic sensations. The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during AHRF.

Trial Health

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Trial Health Score

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

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

February 16, 2012

Status Verified

February 1, 2012

First QC Date

September 13, 2005

Last Update Submit

February 14, 2012

Conditions

Acute Hypercapnic Respiratory Failure

Keywords

Noninvasive ventilationAcute hypercapnic respiratory failureCephalic maskFacial Mask

Outcome Measures

Primary Outcomes (1)

  • Arterial blood gases

Secondary Outcomes (7)

  • Respiratory frequency

  • Severity scores

  • Ventilatory settings

  • Patient-ventilator adaptation

  • Tolerance

  • +2 more secondary outcomes

Interventions

Interface for noninvasive ventilationDEVICE

Eligibility Criteria

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

You may qualify if:

  • Acute hypercapnic respiratory failure
  • Indication to noninvasive ventilation

You may not qualify if:

  • Requirement for endotracheal intubation
  • Proven pulmonary embolism
  • Present or previous history of ophthalmologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary & Intensive Care Department - Rouen University Hospital,

Rouen, 76031, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Antoine CUVELIER, MD, PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

October 1, 2004

Study Completion

February 1, 2006

Last Updated

February 16, 2012

Record last verified: 2012-02

Locations

FR(1)