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Difficulty of recruiting and changing anesthesia methods
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Single-center, randomized study, comparing two methods of oxygenation on 80 patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-flow nasal oxygen therapy | Other | Ventilation with High-flow nasal oxygen therapy |
|
| Flow Controlled Ventilation | Experimental | Ventilation with laryngeal tri-tube with Flow Controlled Ventilation technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Evaluate the quality of the visualization of the laryngeal region in the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morgan Le Guen, Dr | Hopital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Suresnes | 92150 | France |
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| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Flow Controlled Ventilation using a laryngeal tri-tube | Device | Patient in this arm will received a laryngeal tri-tube ventilation during the ENT surgery |
|
Percentage of glottic opening (POGO) score at laryngoscopy |
| 1 day (during surgery) |
| 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) |
| Evaluate the possibility of a decrease in FiO2 (Fraction of inspired oxygen) | Minimal inspired fraction of oxygen during the procedure | 1 day (during surgery) |
| Evaluate the incidence of atelectasis | Incidence of atelectasis on a postoperative chest X ray | 1 day (during surgery) |
| 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) |
| 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 |
| Evaluate the incidence of postoperative complications on day 7 in relation to the technique | Incidence of postoperative complications up to day 7 | 7 days |