Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery

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

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2022-07-18

Brief Summary

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Single-center, randomized study, comparing two methods of oxygenation on 80 patients

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Detailed Description

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This study is a single-center, randomized study, comparing two methods of oxygenation during micro-laryngeal surgery performed under general anesthesia and myorelaxation: high-flow nasal oxygen therapy (HFNO) or Flow Controlled Ventilation (FCV) using a laryngeal tri-tube. The study population will be composed of 80 patients, aged over 18 and under 80.

Conditions

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Laryngeal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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High-flow nasal oxygen therapy

Ventilation with High-flow nasal oxygen therapy

Group Type OTHER

High-flow nasal oxygen therapy using a specific nasal cannula

Intervention Type DEVICE

Patient in this arm will received high-flow nasal oxygen therapy ventilation during the ENT surgery

Flow Controlled Ventilation

Ventilation with laryngeal tri-tube with Flow Controlled Ventilation technique

Group Type EXPERIMENTAL

Flow Controlled Ventilation using a laryngeal tri-tube

Intervention Type DEVICE

Patient in this arm will received a laryngeal tri-tube ventilation during the ENT surgery

Interventions

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High-flow nasal oxygen therapy using a specific nasal cannula

Patient in this arm will received high-flow nasal oxygen therapy ventilation during the ENT surgery

Intervention Type DEVICE

Flow Controlled Ventilation using a laryngeal tri-tube

Patient in this arm will received a laryngeal tri-tube ventilation during the ENT surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient over the age of 18 and under the age of 80
* Patient to benefit from micro-laryngeal ENT surgery under general anesthesia and myorelaxation with an estimated duration which does not exceed 30 minutes
* Having signed a consent form
* Being affiliated with a Health Insurance plan.

Exclusion Criteria

* Pregnant or lactating patient
* Patient with a weight \<40 kg
* Obese patient (BMI\> 30)
* Patient with foreseeable intubation difficulty
* Patient maintained under general anesthesia postoperatively
* Surgery requiring time by surgical laser
* Surgery involving the use of an active electrosurgical electrode in the immediate area of the electrosurgical device or electrode
* Predictable surgery longer than 30 minutes
* Being deprived of liberty or under guardianship.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No