Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?
- Conditions
- Postoperative Oxygen Therapy
- Interventions
- Procedure: Oxygenation is controlled with the patient in a sitting position in the ICU.Procedure: Automated oxygenation with the patient lying down in the ICUProcedure: automated oxygenation with a sitting patient position in the ICU
- Registration Number
- NCT05009628
- Lead Sponsor
- Hopital Foch
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control oxygenation with the patient in a sitting position in the ICU Oxygenation is controlled with the patient in a sitting position in the ICU. - automated oxygenation with the patient lying down in the ICU Automated oxygenation with the patient lying down in the ICU - automated oxygenation with a sitting patient position in the ICU automated oxygenation with a sitting patient position in the ICU -
- Primary Outcome Measures
Name Time Method Oxygen withdrawal time 1 day Time (min) to achieve zero O2 flow for at least 15 consecutive minutes
- Secondary Outcome Measures
Name Time Method Rate of patients weaned within the first hour 1 day Zero O2 flow for at least 15 consecutive minutes
Signature time in the ICU 1 day Minutes since admission
Complications after stay in hospital 30 days Rehospitalization
The patient's comfort 1 day Numerical scale between 0 and 10 to evaluate patient comfort
Mortality during stay in hospital 30 days Hospital mortality
Complications during hospital stay 30 days Length of hospital stay
Complications during stay in intensive care unit 30 days Length of stay in intensive care unit
Amount of O2 needed to reach the target saturation value (SpO2) 1 day Number of liters of O2 needed postoperatively
Maximum flow rate during the evaluation period 1 day Maximum value of O2 flow in liter/min
Trial Locations
- Locations (1)
Hôpital Foch
🇫🇷Suresnes, France