Voice Tessitura and Size of the Required Laryngeal Mask (EVG)

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.

Study Overview

• Status: Completed
• Conditions: Laryngeal Masks
• Intervention / Treatment: Other: General anesthesia with laryngeal mask i-gel

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• France
  • Villeneuve-Saint-Georges, France
    • CHI Villeneuve-Saint-Georges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients up to 10 years old with planned surgery and anticipated use of laryngeal mask i-gel.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal to participate in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
> 18 years	Other: General anesthesia with laryngeal mask i-gel; General anesthesia with laryngeal mask i-gel
10 to 18 years	Other: General anesthesia with laryngeal mask i-gel; General anesthesia with laryngeal mask i-gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance between the weight and the tessitura threshold	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining the tessitura threshold corresponding to each mask size	tessitura threshold (the most serious sound emitted by the patient) corresponding to each mask size	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): September 23, 2019
• Study Completion (ACTUAL): September 24, 2019

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (ACTUAL): August 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: EVG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No