Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery

NCT04369040 | Terminated

• 1 other identifier: 2020_0016
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Laryngeal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  1 day (during surgery)

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

  1 day (during surgery)

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

  1 day (during surgery)

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

  1 day (during surgery)

• Evaluate the incidence of atelectasis

  1 day (during surgery)

Study Arms (2)

High-flow nasal oxygen therapy

OTHER

Ventilation with High-flow nasal oxygen therapy

Device: High-flow nasal oxygen therapy using a specific nasal cannula

Flow Controlled Ventilation

EXPERIMENTAL

Ventilation with laryngeal tri-tube with Flow Controlled Ventilation technique

Device: Flow Controlled Ventilation using a laryngeal tri-tube

Interventions

High-flow nasal oxygen therapy using a specific nasal cannula DEVICE

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

High-flow nasal oxygen therapy

Flow Controlled Ventilation using a laryngeal tri-tube DEVICE

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

Flow Controlled Ventilation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Morgan Le Guen, Dr

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: March 10, 2022
• Primary Completion: July 11, 2022
• Study Completion: July 18, 2022
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)