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The purpose of the study is to assess the optimal fraction of inspired oxygen (0.5 or 1) for extubation or removal of a supraglottic airway device after general anesthesia.
During pre-anesthesia visit, eligible patients receive oral and written information of the study and potential risks.
In the operating room all patients giving a written informed consent will undergo at the end of surgery a screening to determine eligibility for study entry.
Before emergence from general anesthesia, patients who meet the eligibility requirements will be randomized in a open label manner to receive a 0.5 or 1 FiO2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group FiO2=1 | Active Comparator | FiO2 = 1 (100%) 10mn before emergence of general anesthesia |
|
| Intervention Group FiO2 0.5 | Experimental | Fi02 = 0.5 (50%) 10mn before emergence of general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FiO2 0.5 | Other | Ten minutes before emergence from general anesthesia, the amount of oxygen delivered from the mechanical ventilator called fractional inspired oxygen (FiO2) is set to 0.5 (50%) |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of oxygen saturation | Proportions of patients that present a decrease of 4 points of peripheral capillary oxygen saturation (SpO2) measured with pulse oximetry after extubation compared to their baseline room air SpO2 | Duration of stay in post-anesthesia care unit, approximately one hour |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of emergence | Elapsed Time between cessation of sedation and extubation (minutes) | Up to one hour |
| Primary Outcome Timing | Elapsed time between extubation and decrease of oxygen saturation (minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr KAMGA TOTOUOM, MD | Anesthesiologist | Principal Investigator |
| Pr HANOUZ, PhD | Anesthesiologist | Study Director |
| Dr BOUTROS, MD | Anesthesiologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Caen | Caen | 14033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit (EXTUBO2) [abstract]. SFAR 2022 - Livre des résumés; 2022. |
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| D011183 | Postoperative Complications |
| D000860 | Hypoxia |
| D018496 | Hyperoxia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| FiO2 1 | Other | Ten minutes before emergence from general anesthesia, the amount of oxygen delivered from the mechanical ventilator called fractional inspired oxygen (FiO2) is set to 1 (100%) |
|
| Up to one hour |
| Number of risk factors | Number of factors associated with episodes of hypoxemia : bronchospasm, bronchial congestion (profuse secretions with the need to aspirate the patient several times), loss of upper airway muscle tonus (fall of the tongue). | One hour |
| Majored decrease of oxygen saturation | Proportions of patients that present a decrease of 6 points of SpO2 after extubation compared to their baseline room air SpO2 | One hour |
| Corrective measures | Number of corrective measures (method and oxygen supply equipment used) after hypoxemia and proportion of success. | One hour |
| PACU length of stay | Length of stay in post-anesthesia care unit | One hour |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |