An interventional study of FiO2 0.5 and FiO2 1 in Anesthesia, Atelectasis and Postoperative Complications, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
FiO2 = 1 (100%) 10mn before emergence of general anesthesia
Other: FiO2 1
Fi02 = 0.5 (50%) 10mn before emergence of general anesthesia
Other: FiO2 0.5
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%)
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
Time frame: Duration of stay in post-anesthesia care unit, approximately one hour
Duration of emergence
Elapsed Time between cessation of sedation and extubation (minutes)
Time frame: Up to one hour
Primary Outcome Timing
Elapsed time between extubation and decrease of oxygen saturation (minutes)
Time frame: 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).
Time frame: 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
Time frame: One hour
Corrective measures
Number of corrective measures (method and oxygen supply equipment used) after hypoxemia and proportion of success.
Time frame: One hour
PACU length of stay
Length of stay in post-anesthesia care unit
Time frame: One hour
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Caen