Skip to content

Facial Mask Tightness: A Comparative Study

Facial Mask Tightness: A Comparative Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02778984
Acronym
EMAF
Enrollment
70
Registered
2016-05-20
Start date
2016-05-31
Completion date
2018-12-31
Last updated
2019-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Anesthesia, facial mask

Brief 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.

Interventions

DEVICEQuadraLite masks

The intervention is identical in the two group

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
significant leakage (ie greater than 20% of the current volume) between QuadraLite® mask and facial mask10 minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026