Voice Tessitura and Size of the Required Laryngeal Mask

Completed

• Conditions: Laryngeal Masks
• Interventions: Other: General anesthesia with laryngeal mask i-gel

• Registration Number: NCT03619057
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

The choice of the size of the laryngeal mask (i-gel) is based on the weight. Even following the weight recommendations, it is quite common to choose a mask that is too big or too small, which leads to ventilation leaks (too small), or insertion failures (too big) and leads to a change of mask for bigger or smaller.

The i-gel are laryngeal masks (2nd generation) which consist of gel and have been designed by molding on larynx corpses. The masks are not inflatable (so not adaptable).

I-gel masks are used in adult and pediatric patients for weights ranging from 2 Kg to over 90 Kg to provide ventilation during general anesthesia.

Patients with a deep voice probably need a larger laryngeal mask than their weight alone suggests.

The investigators propose to measure the lowest sound emitted by the patient because it would seem logical that the larger the larynx is, the more the voice is serious.

This hypothesis will be verified a posteriori by the size of the laryngeal mask used and adapted by comparing it to the range of the voice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-07
• Study Start: 2018-10-01
• Primary Completion: 2019-09-23
• Study Completion: 2019-09-24
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• Age ≥ 10 years
• Planned surgical procedure with the use of a laryngeal mask

Exclusion Criteria

• Refusal to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
> 18 years	General anesthesia with laryngeal mask i-gel	-
10 to 18 years	General anesthesia with laryngeal mask i-gel	-

Primary Outcome Measures

Name	Time	Method
Concordance between the weight and the tessitura threshold	1 day	Concordance between the size of the mask proposed as a function of the weight and that determined after determination of the tessitura threshold for each mask size by ROC curves.

Secondary Outcome Measures

Name	Time	Method
Determining the tessitura threshold corresponding to each mask size	1 day	tessitura threshold (the most serious sound emitted by the patient) corresponding to each mask size

Trial Locations

Locations (1)

CHI Villeneuve-Saint-Georges; 🇫🇷 Villeneuve-Saint-Georges, France