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OpenTrials
Completed

NCT Number: NCT03619057

Voice Tessitura and Size of the Required Laryngeal Mask

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.

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Key information

Conditions

Laryngeal Masks

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHI Villeneuve-Saint-Georges

Villeneuve-Saint-Georges, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal to participate in the study.

Treatment and study plan

General anesthesia with laryngeal mask i-gel

Other

General anesthesia with laryngeal mask i-gel

Primary outcomes

  1. Concordance between the weight and the tessitura threshold

    Time frame: 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 outcomes

  1. Determining the tessitura threshold corresponding to each mask size

    Time frame: 1 day

    tessitura threshold (the most serious sound emitted by the patient) corresponding to each mask size

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Acronym: EVG

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2018
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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