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Clinical Trials/NCT05009628
NCT05009628
Completed
Not Applicable

Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?

Hopital Foch1 site in 1 country80 target enrollmentJuly 5, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Oxygen Therapy
Sponsor
Hopital Foch
Enrollment
80
Locations
1
Primary Endpoint
Oxygen withdrawal time
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 5, 2021
End Date
November 27, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Oxygen withdrawal time

Time Frame: 1 day

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

Secondary Outcomes

  • Rate of patients weaned within the first hour(1 day)
  • Signature time in the ICU(1 day)
  • Complications after stay in hospital(30 days)
  • The patient's comfort(1 day)
  • Mortality during stay in hospital(30 days)
  • Complications during stay in intensive care unit(30 days)
  • Complications during hospital stay(30 days)
  • Amount of O2 needed to reach the target saturation value (SpO2)(1 day)
  • Maximum flow rate during the evaluation period(1 day)

Study Sites (1)

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