Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery

Laryngeal Disease Clinical Trial

— FCVT-ENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04369040
• Other study ID #: 2020_0016
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: March 17, 2023

Study information

• Verified date: August 2022
• Source: Hopital Foch
• Contact: Elisabeth Hulier-Ammar, Dr
• Phone: 0033146251175
• Email: e.hulier-ammar[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 17, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laryngeal Disease
• Laryngeal Diseases

Intervention

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
• Flow Controlled Ventilation using a laryngeal tri-tube
Patient in this arm will received a laryngeal tri-tube ventilation during the ENT surgery

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Evaluate the possibility of a decrease in FiO2 (Fraction of inspired oxygen)	Minimal inspired fraction of oxygen during the procedure	1 day (during surgery)
Secondary	Evaluate the incidence of atelectasis	Incidence of atelectasis on a postoperative chest X ray	1 day (during surgery)
Secondary	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)
Secondary	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
Secondary	Evaluate the incidence of postoperative complications on day 7 in relation to the technique	Incidence of postoperative complications up to day 7	7 days