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NCT02778984 Clinical Trial

Facial Mask Tightness: A Comparative Study

Anesthesia Clinical Trial

— EMAF  

Official title:
Facial Mask Tightness: A Comparative Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02778984
Other study ID # I15035
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date December 2018

Study information
Verified date May 2017
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A correct preoxygenation can be obtained after a 3min delay of calm ventilation through a tight mask thereafter mask is used to make the patient breathing before intubation. Most tight masks are actually sold but they have never been compared in studies. The aim of this study is to compare air leaks with standard facial mask and QuadraLite masks during preoxygenation and induction of anesthesia.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date December 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria:

- edentulous patients

- age > 55 years

Exclusion Criteria:

- pregnancy or breast-feeding, patients on tutelage or guardianship

- patient unable to understand the protocol

- anesthesia in emergency or with full stomach

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• QuadraLite masks
The intervention is identical in the two group
Other:
• standard mask

Locations
Country Name City State
France Limoges Hospital Limoges

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary significant leakage (ie greater than 20% of the current volume) between QuadraLite® mask and facial mask 10 minutes
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