Voice Tessitura and Size of the Required Laryngeal Mask

NCT03619057 | Completed

• 1 other identifier: EVG
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Masks

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determining the tessitura threshold corresponding to each mask size

  1 day

Study Arms (2)

> 18 years

Other: General anesthesia with laryngeal mask i-gel

10 to 18 years

Other: General anesthesia with laryngeal mask i-gel

Interventions

General anesthesia with laryngeal mask i-gel OTHER

General anesthesia with laryngeal mask i-gel

10 to 18 years; > 18 years

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Refusal to participate in the study.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

CHI Villeneuve-Saint-Georges

Villeneuve-Saint-Georges, France

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 7, 2018
• Study Start: October 1, 2018
• Primary Completion: September 23, 2019
• Study Completion: September 24, 2019
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)