Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213395
Status:
TERMINATED
Last Update Posted:
2012-02-16
First Post:
2005-09-13
Brief Title:
Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None