University Hospital, Caen
Caen, 14033, France
NCT Number: NCT04879290
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Caen, 14033, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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%)
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%)
Time frame: Duration of stay in post-anesthesia care unit, approximately one hour
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
Time frame: Up to one hour
Elapsed Time between cessation of sedation and extubation (minutes)
Time frame: Up to one hour
Elapsed time between extubation and decrease of oxygen saturation (minutes)
Time frame: One hour
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).
Time frame: One hour
Proportions of patients that present a decrease of 6 points of SpO2 after extubation compared to their baseline room air SpO2
Time frame: One hour
Number of corrective measures (method and oxygen supply equipment used) after hypoxemia and proportion of success.
Time frame: One hour
Length of stay in post-anesthesia care unit
University Hospital, Caen
Other
Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit : a Monocentric Randomized Trial
Acronym: EXTUBO2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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