Voice Tessitura and Size of the Required Laryngeal Mask

Laryngeal Masks Clinical Trial

— EVG  

Official title:

Voice Tessitura and Size of the Required Laryngeal Mask

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619057
• Other study ID #: EVG
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: September 24, 2019

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: September 24, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Age = 10 years

• Planned surgical procedure with the use of a laryngeal mask

Exclusion Criteria:

• Refusal to participate in the study.

Related Conditions & MeSH terms

• Laryngeal Masks

Intervention

Other:
• General anesthesia with laryngeal mask i-gel
General anesthesia with laryngeal mask i-gel

Locations

Country	Name	City	State
France	CHI Villeneuve-Saint-Georges	Villeneuve-Saint-Georges

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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