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

Primary Purpose

Laryngeal Disease

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

High-flow nasal oxygen therapy using a specific nasal cannula

Flow Controlled Ventilation using a laryngeal tri-tube

About this trial

This is an interventional other trial for Laryngeal Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Hopital FochRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

High-flow nasal oxygen therapy

Flow Controlled Ventilation

Arm Description

Ventilation with High-flow nasal oxygen therapy

Ventilation with laryngeal tri-tube with Flow Controlled Ventilation technique

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate the duration of oxygen therapy before desaturation in the two groups

Delay before oxygen desaturation (SpO2<92%) during the procedure

Evaluate the quality of the visualization of the laryngeal region in the two groups

Percentage of glottic opening (POGO) score at laryngoscopy

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

Evaluate the possibility of a decrease in FiO2 (Fraction of inspired oxygen)

Minimal inspired fraction of oxygen during the procedure

Evaluate the incidence of atelectasis

Incidence of atelectasis on a postoperative chest X ray

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

Evaluate the incidence of postoperative complications on day 1 in relation to the technique

Incidence of postoperative complications at day 1 after the surgery

Evaluate the incidence of postoperative complications on day 7 in relation to the technique

Incidence of postoperative complications up to day 7

Full Information

NCT ID

NCT04369040

First Posted

April 28, 2020

Last Updated

August 2, 2022

Sponsor

Hopital Foch

1. Study Identification

Unique Protocol Identification Number

NCT04369040

Brief Title

Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery

Acronym

FCVT-ENT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 10, 2022 (Actual)

Primary Completion Date

March 10, 2023 (Anticipated)

Study Completion Date

March 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laryngeal Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High-flow nasal oxygen therapy

Arm Type

Other

Arm Description

Ventilation with High-flow nasal oxygen therapy

Arm Title

Flow Controlled Ventilation

Arm Type

Experimental

Arm Description

Ventilation with laryngeal tri-tube with Flow Controlled Ventilation technique

Intervention Type

Device

Intervention Name(s)

High-flow nasal oxygen therapy using a specific nasal cannula

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Flow Controlled Ventilation using a laryngeal tri-tube

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

% of patients having an oxygen desaturation (SpO2<92%) during the procedure OR a PaCO2 > 65 mmHg at its end

Time Frame

1 day (during surgery)

Secondary Outcome Measure Information:

Title

Evaluate the duration of oxygen therapy before desaturation in the two groups

Description

Delay before oxygen desaturation (SpO2<92%) during the procedure

Time Frame

1 day (during surgery)

Title

Evaluate the quality of the visualization of the laryngeal region in the two groups

Description

Percentage of glottic opening (POGO) score at laryngoscopy

Time Frame

1 day (during surgery)

Title

Evaluate the time-PaCO2 (partial pressure of carbon dioxide) relationship according to the techniques

Description

PaCO2 (partial pressure of carbon dioxide) at the end of the procedure

Time Frame

1 day (during surgery)

Title

Evaluate the possibility of a decrease in FiO2 (Fraction of inspired oxygen)

Description

Minimal inspired fraction of oxygen during the procedure

Time Frame

1 day (during surgery)

Title

Evaluate the incidence of atelectasis

Description

Incidence of atelectasis on a postoperative chest X ray

Time Frame

1 day (during surgery)

Title

Evaluate the time taken to resume spontaneous ventilation and wake up when the anesthetic agents are stopped

Description

Delay between the end of administration of anesthetic drugs and return to spontaneous ventilation

Time Frame

1 day (during surgery)

Title

Evaluate the incidence of postoperative complications on day 1 in relation to the technique

Description

Incidence of postoperative complications at day 1 after the surgery

Time Frame

1 day

Title

Evaluate the incidence of postoperative complications on day 7 in relation to the technique

Description

Incidence of postoperative complications up to day 7

Time Frame

7 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elisabeth Hulier-Ammar, Dr

Phone

0033146251175

e.hulier-ammar@hopital-foch.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Morgan Le Guen, Dr

Organizational Affiliation

Hopital Foch

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Foch

City

Suresnes

ZIP/Postal Code

92150

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Morgan Le Guen, Dr

m.leguen@hopital-foch.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery

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