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Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?

Not Applicable
Completed
Conditions
Postoperative Oxygen Therapy
Interventions
Procedure: Oxygenation is controlled with the patient in a sitting position in the ICU.
Procedure: Automated oxygenation with the patient lying down in the ICU
Procedure: automated oxygenation with a sitting patient position in the ICU
Registration Number
NCT05009628
Lead Sponsor
Hopital Foch
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
control oxygenation with the patient in a sitting position in the ICUOxygenation is controlled with the patient in a sitting position in the ICU.-
automated oxygenation with the patient lying down in the ICUAutomated oxygenation with the patient lying down in the ICU-
automated oxygenation with a sitting patient position in the ICUautomated oxygenation with a sitting patient position in the ICU-
Primary Outcome Measures
NameTimeMethod
Oxygen withdrawal time1 day

Time (min) to achieve zero O2 flow for at least 15 consecutive minutes

Secondary Outcome Measures
NameTimeMethod
Rate of patients weaned within the first hour1 day

Zero O2 flow for at least 15 consecutive minutes

Signature time in the ICU1 day

Minutes since admission

Complications after stay in hospital30 days

Rehospitalization

The patient's comfort1 day

Numerical scale between 0 and 10 to evaluate patient comfort

Mortality during stay in hospital30 days

Hospital mortality

Complications during hospital stay30 days

Length of hospital stay

Complications during stay in intensive care unit30 days

Length of stay in intensive care unit

Amount of O2 needed to reach the target saturation value (SpO2)1 day

Number of liters of O2 needed postoperatively

Maximum flow rate during the evaluation period1 day

Maximum value of O2 flow in liter/min

Trial Locations

Locations (1)

Hôpital Foch

🇫🇷

Suresnes, France

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