Hôpital Foch
Suresnes, 92150, France
NCT Number: NCT05009628
The purpose of this study by automated control of oxygen supply in the immediate postoperative period is to show the possibility of immediate weaning in the postoperative period in case of remifentanil use and complete reversion of curarization.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Suresnes, 92150, France
The main hypothesis of this study is that classical oxygen therapy at 3l/min is futile in the postoperative period of a so-called modern anaesthesia and that a total weaning within one hour after arrival in the ICU is possible whatever the postoperative position of the patient. The aim is therefore to include patients who have to undergo a scheduled surgery under anaesthetic sedation (analgesia with remifentanil) or general anaesthesia (combining remifentanil, propofol rocuronium) for ambulatory surgery. The trial is interventional, randomized, monocentric to demonstrate the absence of interest of prolonged postoperative oxygen therapy under specific intraoperative conditions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oxygenation will be done with the Free O2 device via oxygen goggles or a face mask and with an O2 prescription to obtain a SpO2> 94%. The patient's position in the ICU will be a sitting position with the chest raised at an angle greater than 45°.
Oxygenation will be done with the Free O2 device via oxygen goggles or a face mask and with an O2 prescription to obtain a SpO2> 94%. The patient's position in the ICU will be a recumbent position with the head elevated to a maximum of 10
ICU. Oxygenation will be done via the same interface in manual mode where the post-interventional monitoring room nurse modifies the flow to maintain oxygen saturation above 94%. The patient's position in the ICU will be a sitting position with the chest raised at an angle greater than 45°.
Time frame: 1 day
Time (min) to achieve zero O2 flow for at least 15 consecutive minutes
Time frame: 1 day
Number of liters of O2 needed postoperatively
Time frame: 1 day
Zero O2 flow for at least 15 consecutive minutes
Time frame: 1 day
Minutes since admission
Time frame: 1 day
Maximum value of O2 flow in liter/min
Time frame: 1 day
Numerical scale between 0 and 10 to evaluate patient comfort
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
Length of stay in intensive care unit
Time frame: 30 days
Hospital mortality
Time frame: 30 days
Rehospitalization
Hopital Foch
Other
Acronym: FreeO2
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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.