Facial Mask Tightness: A Comparative Study

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.

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Key information

Conditions

Anesthesia

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limoges Hospital

Limoges, 87 042, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QuadraLite masks

Device

The intervention is identical in the two group

standard mask

Other

Primary outcomes

significant leakage (ie greater than 20% of the current volume) between QuadraLite® mask and facial mask

Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: EMAF

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: May 20, 2016
Registry last updated: Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed