Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery (FCVT-ENT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Laryngeal Disease
• Intervention / Treatment: Device: High-flow nasal oxygen therapy using a specific nasal cannula; Device: Flow Controlled Ventilation using a laryngeal tri-tube

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth Hulier-Ammar, Dr; Phone Number: 0033146251175; Email: e.hulier-ammar@hopital-foch.com

Study Locations

• France
  • Suresnes, France, 92150
    • Recruiting
    • Hopital FOCH
    • Contact: Morgan Le Guen, Dr; Email: m.leguen@hopital-foch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Morgan Le Guen, Dr, Hopital FOCH

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Anticipated): March 10, 2023
• Study Completion (Anticipated): March 17, 2023

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases
• Other Study ID Numbers: 2020_0016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No