Clinical trial NCT04369040: Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery
Official title: Comparison of Two Ventilation Systems in Laryngeal Surgery: High-flow Nasal Oxygen Therapy and Laryngeal Micro-catheter With the Ventinova Technique
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laryngeal Disease
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: 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).
timeFrame: 1 day (during surgery)
Secondary outcomes:
measure: Evaluate the duration of oxygen therapy before desaturation in the two groups
timeFrame: 1 day (during surgery)
measure: Evaluate the quality of the visualization of the laryngeal region in the two groups
timeFrame: 1 day (during surgery)
measure: Evaluate the time-PaCO2 (partial pressure of carbon dioxide) relationship according to the techniques
timeFrame: 1 day (during surgery)
measure: Evaluate the possibility of a decrease in FiO2 (Fraction of inspired oxygen)
timeFrame: 1 day (during surgery)
measure: Evaluate the incidence of atelectasis
timeFrame: 1 day (during surgery)
measure: Evaluate the time taken to resume spontaneous ventilation and wake up when the anesthetic agents are stopped
timeFrame: 1 day (during surgery)
measure: Evaluate the incidence of postoperative complications on day 1 in relation to the technique
timeFrame: 1 day
measure: Evaluate the incidence of postoperative complications on day 7 in relation to the technique
timeFrame: 7 days
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Morgan Le Guen, Dr
role: PRINCIPAL_INVESTIGATOR
References: