Clinical trial NCT05009628: Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?
Official title: Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Oxygen Therapy
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: interventional study with 4 paralel arms ; randomization is realised according to a centralized and balanced 2x2 factorial design
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients managed by the Anesthesia Department of the Foch Hospital;
* Anesthetic sedation (analgesia with remifentanil) or general anesthesia (combining remifentanil, propofol and possibly rocuronium);
* Men or women over 18 and under 80 years of age;
* To benefit from a surgical intervention scheduled \> 48 hours in relation to the procedure;
* Scheduled outpatient surgery;
* Have signed a consent form;
* Be affiliated to a health insurance plan.

Exclusion Criteria:

* Pregnant or nursing patients;
* Oxygen dependent preoperatively or at risk of oxygen dependence postoperatively;
* Lung resection surgery;
* Brain surgery (intracerebral neurosurgery); ENT surgery requiring a half-seated position after the operation;
* Being deprived of liberty or under guardianship.

Primary outcomes:
measure: Oxygen withdrawal time
timeFrame: 1 day
Secondary outcomes:
measure: Amount of O2 needed to reach the target saturation value (SpO2)
timeFrame: 1 day
measure: Rate of patients weaned within the first hour
timeFrame: 1 day
measure: Signature time in the ICU
timeFrame: 1 day
measure: Maximum flow rate during the evaluation period
timeFrame: 1 day
measure: The patient's comfort
timeFrame: 1 day
measure: Complications during hospital stay
timeFrame: 30 days
measure: Complications during stay in intensive care unit
timeFrame: 30 days
measure: Mortality during stay in hospital
timeFrame: 30 days
measure: Complications after stay in hospital
timeFrame: 30 days
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
References: