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Completed

NCT Number: NCT05009628

Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Foch

Suresnes, 92150, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

automated oxygenation with a sitting patient position in the ICU

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°.

Automated oxygenation with the patient lying down in the ICU

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

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

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°.

Primary outcomes

  1. Oxygen withdrawal time

    Time frame: 1 day

    Time (min) to achieve zero O2 flow for at least 15 consecutive minutes

Secondary outcomes

  1. Amount of O2 needed to reach the target saturation value (SpO2)

    Time frame: 1 day

    Number of liters of O2 needed postoperatively

  2. Rate of patients weaned within the first hour

    Time frame: 1 day

    Zero O2 flow for at least 15 consecutive minutes

  3. Signature time in the ICU

    Time frame: 1 day

    Minutes since admission

  4. Maximum flow rate during the evaluation period

    Time frame: 1 day

    Maximum value of O2 flow in liter/min

  5. The patient's comfort

    Time frame: 1 day

    Numerical scale between 0 and 10 to evaluate patient comfort

  6. Complications during hospital stay

    Time frame: 30 days

    Length of hospital stay

  7. Complications during stay in intensive care unit

    Time frame: 30 days

    Length of stay in intensive care unit

  8. Mortality during stay in hospital

    Time frame: 30 days

    Hospital mortality

  9. Complications after stay in hospital

    Time frame: 30 days

    Rehospitalization

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: FreeO2

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2021
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.