Is Routine Postoperative Oxygen Therapy Still Necessary in 2020? (FreeO2)

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Oxygen Therapy
• Intervention / Treatment: Procedure: automated oxygenation with a sitting patient position in the ICU; Procedure: Automated oxygenation with the patient lying down in the ICU; Procedure: Oxygenation is controlled with the patient in a sitting position in the ICU.

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92150
    • Hôpital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: automated oxygenation with a sitting patient position in the ICU	Procedure: automated oxygenation with a sitting patient position in the ICU; 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°.
No Intervention: controlled oxygenation with a lying patient position in the ICU
Experimental: automated oxygenation with the patient lying down in the ICU	Procedure: Automated oxygenation with the patient lying down in the ICU; 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
Experimental: control oxygenation with the patient in a sitting position in the ICU	Procedure: Oxygenation is controlled with the patient in a sitting position in the ICU.; 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°.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen withdrawal time	Time (min) to achieve zero O2 flow for at least 15 consecutive minutes	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of O2 needed to reach the target saturation value (SpO2)	Number of liters of O2 needed postoperatively	1 day
Rate of patients weaned within the first hour	Zero O2 flow for at least 15 consecutive minutes	1 day
Signature time in the ICU	Minutes since admission	1 day
Maximum flow rate during the evaluation period	Maximum value of O2 flow in liter/min	1 day
The patient's comfort	Numerical scale between 0 and 10 to evaluate patient comfort	1 day
Complications during hospital stay	Length of hospital stay	30 days
Complications during stay in intensive care unit	Length of stay in intensive care unit	30 days
Mortality during stay in hospital	Hospital mortality	30 days
Complications after stay in hospital	Rehospitalization	30 days

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): November 27, 2021
• Study Completion (Actual): November 27, 2021

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2019_0006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No