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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04369040
Other study ID # 2020_0016
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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