Facial Mask Tightness: A Comparative Study

Not Applicable

Completed

• Conditions: Anesthesia

• Registration Number: NCT02778984
• Lead Sponsor: University Hospital, Limoges

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-20
• Status Verified: 2017-05
• Primary Completion: 2018-08
• Study Completion: 2018-12
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
significant leakage (ie greater than 20% of the current volume) between QuadraLite® mask and facial mask	10 minutes

Trial Locations

Locations (1)

Limoges Hospital; 🇫🇷 Limoges, France