Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery

Not Applicable

• Conditions: Laryngeal Disease
• Interventions: Device: Flow Controlled Ventilation using a laryngeal tri-tube; Device: High-flow nasal oxygen therapy using a specific nasal cannula

• Registration Number: NCT04369040
• Lead Sponsor: Hopital Foch

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-30
• Study Start: 2022-03-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flow Controlled Ventilation	Flow Controlled Ventilation using a laryngeal tri-tube	Ventilation with laryngeal tri-tube with Flow Controlled Ventilation technique
High-flow nasal oxygen therapy	High-flow nasal oxygen therapy using a specific nasal cannula	Ventilation with High-flow nasal oxygen therapy

Primary Outcome Measures

Name	Time	Method
Compare the percentage of patients having oxygen desaturation during the procedure or a PaCO2 > 65 mmHg at its end with both methods (high-flow nasal oxygen therapy and the use of FCV modality via a laryngeal tri-tube).	1 day (during surgery)	% of patients having an oxygen desaturation (SpO2\<92%) during the procedure OR a PaCO2 \> 65 mmHg at its end

Secondary Outcome Measures

Name	Time	Method
Evaluate the incidence of atelectasis	1 day (during surgery)	Incidence of atelectasis on a postoperative chest X ray
Evaluate the duration of oxygen therapy before desaturation in the two groups	1 day (during surgery)	Delay before oxygen desaturation (SpO2\<92%) during the procedure
Evaluate the incidence of postoperative complications on day 1 in relation to the technique	1 day	Incidence of postoperative complications at day 1 after the surgery
Evaluate the quality of the visualization of the laryngeal region in the two groups	1 day (during surgery)	Percentage of glottic opening (POGO) score at laryngoscopy
Evaluate the time-PaCO2 (partial pressure of carbon dioxide) relationship according to the techniques	1 day (during surgery)	PaCO2 (partial pressure of carbon dioxide) at the end of the procedure
Evaluate the time taken to resume spontaneous ventilation and wake up when the anesthetic agents are stopped	1 day (during surgery)	Delay between the end of administration of anesthetic drugs and return to spontaneous ventilation
Evaluate the possibility of a decrease in FiO2 (Fraction of inspired oxygen)	1 day (during surgery)	Minimal inspired fraction of oxygen during the procedure
Evaluate the incidence of postoperative complications on day 7 in relation to the technique	7 days	Incidence of postoperative complications up to day 7

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France