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Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure

Primary Purpose

Acute Hypercapnic Respiratory Failure

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interface for noninvasive ventilation
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypercapnic Respiratory Failure focused on measuring Noninvasive ventilation, Acute hypercapnic respiratory failure, Cephalic mask, Facial Mask

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Acute hypercapnic respiratory failure Indication to noninvasive ventilation Exclusion Criteria: Requirement for endotracheal intubation Proven pulmonary embolism Present or previous history of ophthalmologic disease

Sites / Locations

  • Pulmonary & Intensive Care Department - Rouen University Hospital,

Outcomes

Primary Outcome Measures

Arterial blood gases

Secondary Outcome Measures

Respiratory frequency
Severity scores
Ventilatory settings
Patient-ventilator adaptation
Tolerance
Outcome
Complications

Full Information

First Posted
September 13, 2005
Last Updated
February 14, 2012
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT00213395
Brief Title
Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Rouen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypercapnic Respiratory Failure
Keywords
Noninvasive ventilation, Acute hypercapnic respiratory failure, Cephalic mask, Facial Mask

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Interface for noninvasive ventilation
Primary Outcome Measure Information:
Title
Arterial blood gases
Secondary Outcome Measure Information:
Title
Respiratory frequency
Title
Severity scores
Title
Ventilatory settings
Title
Patient-ventilator adaptation
Title
Tolerance
Title
Outcome
Title
Complications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute hypercapnic respiratory failure Indication to noninvasive ventilation Exclusion Criteria: Requirement for endotracheal intubation Proven pulmonary embolism Present or previous history of ophthalmologic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine CUVELIER, MD, PhD
Organizational Affiliation
University Hospital, Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary & Intensive Care Department - Rouen University Hospital,
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Learn more about this trial

Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure

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