Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit (EXTUBO2)

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Anesthesia; Hypoxemia; Hyperoxia; Atelectasis
• Intervention / Treatment: Other: FiO2 1; Other: FiO2 0.5

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • University Hospital, Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group FiO2=1; FiO2 = 1 (100%) 10mn before emergence of general anesthesia	Other: FiO2 1; 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%)
Experimental: Intervention Group FiO2 0.5; Fi02 = 0.5 (50%) 10mn before emergence of general anesthesia	Other: FiO2 0.5; 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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease of oxygen saturation	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	Duration of stay in post-anesthesia care unit, approximately one hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of emergence	Elapsed Time between cessation of sedation and extubation (minutes)	Up to one hour
Primary Outcome Timing	Elapsed time between extubation and decrease of oxygen saturation (minutes)	Up to one hour
Number of risk factors	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).	One hour
Majored decrease of oxygen saturation	Proportions of patients that present a decrease of 6 points of SpO2 after extubation compared to their baseline room air SpO2	One hour
Corrective measures	Number of corrective measures (method and oxygen supply equipment used) after hypoxemia and proportion of success.	One hour
PACU length of stay	Length of stay in post-anesthesia care unit	One hour

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Dr KAMGA TOTOUOM, MD, Anesthesiologist; Study Director: Pr HANOUZ, PhD, Anesthesiologist; Principal Investigator: Dr BOUTROS, MD, Anesthesiologist

Publications and helpful links

General Publications

• Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit (EXTUBO2) [abstract]. SFAR 2022 - Livre des résumés; 2022.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Actual): August 16, 2021
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Extubation; Post-anesthesia care unit
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia; Pulmonary Atelectasis; Postoperative Complications; Hyperoxia
• Other Study ID Numbers: 19-172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No