Trials / Completed
CompletedNCT05009628
Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Hopital Foch · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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°. |
| 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 |
| 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°. |
Timeline
- Start date
- 2021-07-05
- Primary completion
- 2021-11-27
- Completion
- 2021-11-27
- First posted
- 2021-08-17
- Last updated
- 2022-01-19
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05009628. Inclusion in this directory is not an endorsement.