Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?

NCT ID: NCT05009628

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-05
• Study Completion Date: 2021-11-27

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.

Conditions

Postoperative Oxygen Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

automated oxygenation with a sitting patient position in the ICU

Group Type: EXPERIMENTAL

automated oxygenation with a sitting patient position in the ICU

Intervention Type: PROCEDURE

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°.

controlled oxygenation with a lying patient position in the ICU

Group Type: NO_INTERVENTION

No interventions assigned to this group

automated oxygenation with the patient lying down in the ICU

Group Type: EXPERIMENTAL

Automated oxygenation with the patient lying down in the ICU

Intervention Type: PROCEDURE

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

control oxygenation with the patient in a sitting position in the ICU

Group Type: EXPERIMENTAL

Oxygenation is controlled with the patient in a sitting position in the ICU.

Intervention Type: PROCEDURE

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°.

Interventions

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°.

Intervention Type: 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

Intervention Type: 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°.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Foch

Suresnes, , France

Countries

France

Other Identifiers

2019_0006

Identifier Type: -

Identifier Source: org_study_id