Laryngeal Disease
Conditions
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.
Interventions
DEVICEHigh-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
DEVICEFlow Controlled Ventilation using a laryngeal tri-tube
Patient in this arm will received a laryngeal tri-tube ventilation during the ENT surgery
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 1 day (during surgery) | % of patients having an oxygen desaturation (SpO2\<92%) during the procedure OR a PaCO2 \> 65 mmHg at its end |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the quality of the visualization of the laryngeal region in the two groups | 1 day (during surgery) | Percentage of glottic opening (POGO) score at laryngoscopy |
| Evaluate the time-PaCO2 (partial pressure of carbon dioxide) relationship according to the techniques | 1 day (during surgery) | PaCO2 (partial pressure of carbon dioxide) at the end of the procedure |
| Evaluate the possibility of a decrease in FiO2 (Fraction of inspired oxygen) | 1 day (during surgery) | Minimal inspired fraction of oxygen during the procedure |
| Evaluate the duration of oxygen therapy before desaturation in the two groups | 1 day (during surgery) | Delay before oxygen desaturation (SpO2\<92%) during the procedure |
| Evaluate the time taken to resume spontaneous ventilation and wake up when the anesthetic agents are stopped | 1 day (during surgery) | 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 | 1 day | Incidence of postoperative complications at day 1 after the surgery |
| Evaluate the incidence of postoperative complications on day 7 in relation to the technique | 7 days | Incidence of postoperative complications up to day 7 |
| Evaluate the incidence of atelectasis | 1 day (during surgery) | Incidence of atelectasis on a postoperative chest X ray |
Countries
France
Outcome results
None listed