Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery

Study Overview
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Brief Summary
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Single-center, randomized study, comparing two methods of oxygenation on 80 patients

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.

Official Title
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Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery: High-flow Nasal Oxygen Therapy and Flow Controlled Ventilation

Conditions
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Laryngeal Disease

Intervention / Treatment
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* Device: High-flow nasal oxygen therapy using a specific nasal cannula
* Device: Flow Controlled Ventilation using a laryngeal tri-tube


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High-flow nasal oxygen therapy<br>Ventilation with High-flow nasal oxygen therapy | Device: High-flow nasal oxygen therapy using a specific nasal cannula<br>* Patient in this arm will received high-flow nasal oxygen therapy ventilation during the ENT surgery<br>|
| Experimental: Flow Controlled Ventilation<br>Ventilation with laryngeal tri-tube with Flow Controlled Ventilation technique | Device: Flow Controlled Ventilation using a laryngeal tri-tube<br>* Patient in this arm will received a laryngeal tri-tube ventilation during the ENT surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | % of patients having an oxygen desaturation (SpO2<92%) during the procedure OR a PaCO2 > 65 mmHg at its end | 1 day (during surgery) | 

Secondary Outcome Measures

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