Clinical Trials Directory

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

TypeNameDescription
PROCEDUREautomated oxygenation with a sitting patient position in the ICUOxygenation 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°.
PROCEDUREAutomated oxygenation with the patient lying down in the ICUOxygenation 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
PROCEDUREOxygenation 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.