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Completed

NCT Number: NCT04879290

Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit

The purpose of the study is to assess the optimal fraction of inspired oxygen (0.5 or 1) for extubation or removal of a supraglottic airway device after general anesthesia.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Caen

Caen, 14033, France

About this study

During pre-anesthesia visit, eligible patients receive oral and written information of the study and potential risks.

In the operating room all patients giving a written informed consent will undergo at the end of surgery a screening to determine eligibility for study entry.

Before emergence from general anesthesia, patients who meet the eligibility requirements will be randomized in a open label manner to receive a 0.5 or 1 FiO2.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing general anesthesia, with invasive mechanical ventilation including an airway device (supraglottic airway device or tracheal tube) at their arrival in PACU.
  • ASA physical status classification 1, 2, or 3 stabilized.
  • Surgery performed in emergency operating room department including vascular, digestive, urological and minor trauma surgery or surgery performed in head and neck anesthesia pole block including anterior cervical spine, lumbar disc herniation, cranioplasty, nerve stimulator, vertebroplasty, narrow lumbar canal, simple arthrodesis (less than or equal to two stages), otological, ophthalmological and skin surgery.

Exclusion criteria

  • Per-operative hemodynamic instability.
  • Patients with a BMI greater than 35.
  • Patients classified as difficult to intubate and / or ventilate.
  • Heavy surgeries (operating time greater than 4 hours).
  • Patient requiring postoperative non invasive mechanical ventilation
  • Patients with diagnosed COPD
  • SPO2 in room air < 96% before the intervention.
  • Any patient under guardianship.
  • Pre-operative and / or intra-operative morphine intake.
  • Surgical management of the upper airways (ex : tonsillectomy)
  • Pregnant and lactating women.

Treatment and study plan

FiO2 0.5

Other

Ten minutes before emergence from general anesthesia, the amount of oxygen delivered from the mechanical ventilator called fractional inspired oxygen (FiO2) is set to 0.5 (50%)

FiO2 1

Other

Ten minutes before emergence from general anesthesia, the amount of oxygen delivered from the mechanical ventilator called fractional inspired oxygen (FiO2) is set to 1 (100%)

Primary outcomes

  1. Decrease of oxygen saturation

    Time frame: Duration of stay in post-anesthesia care unit, approximately one hour

    Proportions of patients that present a decrease of 4 points of peripheral capillary oxygen saturation (SpO2) measured with pulse oximetry after extubation compared to their baseline room air SpO2

Secondary outcomes

  1. Duration of emergence

    Time frame: Up to one hour

    Elapsed Time between cessation of sedation and extubation (minutes)

  2. Primary Outcome Timing

    Time frame: Up to one hour

    Elapsed time between extubation and decrease of oxygen saturation (minutes)

  3. Number of risk factors

    Time frame: One hour

    Number of factors associated with episodes of hypoxemia : bronchospasm, bronchial congestion (profuse secretions with the need to aspirate the patient several times), loss of upper airway muscle tonus (fall of the tongue).

  4. Majored decrease of oxygen saturation

    Time frame: One hour

    Proportions of patients that present a decrease of 6 points of SpO2 after extubation compared to their baseline room air SpO2

  5. Corrective measures

    Time frame: One hour

    Number of corrective measures (method and oxygen supply equipment used) after hypoxemia and proportion of success.

  6. PACU length of stay

    Time frame: One hour

    Length of stay in post-anesthesia care unit

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit : a Monocentric Randomized Trial

Acronym: EXTUBO2

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 10, 2021
Registry last updated
Apr 2, 2026

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.

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