Voice Tessitura and Size of the Required Laryngeal Mask

NCT ID: NCT03619057

Last Updated: 2020-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-09-24

Brief Summary

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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

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Conditions

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Laryngeal Masks

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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> 18 years

General anesthesia with laryngeal mask i-gel

Intervention Type OTHER

General anesthesia with laryngeal mask i-gel

10 to 18 years

General anesthesia with laryngeal mask i-gel

Intervention Type OTHER

General anesthesia with laryngeal mask i-gel

Interventions

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General anesthesia with laryngeal mask i-gel

General anesthesia with laryngeal mask i-gel

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

• Refusal to participate in the study.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHI Villeneuve-Saint-Georges

Villeneuve-Saint-Georges, , France

Site Status

Countries

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France

Other Identifiers

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EVG

Identifier Type: -

Identifier Source: org_study_id

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