Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?

Conditions
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Postoperative Oxygen Therapy

Intervention / Treatment
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* 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.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: interventional study with 4 paralel arms ; randomization is realised according to a centralized and balanced 2x2 factorial design
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |