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

NCT04879290 | Completed DMC

• 1 other identifier: 19-172
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Atelectasis; Postoperative Complications; Hypoxemia; Hyperoxia

Keywords

Post-anesthesia care unit; Extubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of emergence

  Up to one hour

• Primary Outcome Timing

  Up to one hour

• Number of risk factors

  One hour

• Majored decrease of oxygen saturation

  One hour

• Corrective measures

  One hour

Study Arms (2)

Control Group FiO2=1

ACTIVE COMPARATOR

FiO2 = 1 (100%) 10mn before emergence of general anesthesia

Other: FiO2 1

Intervention Group FiO2 0.5

EXPERIMENTAL

Fi02 = 0.5 (50%) 10mn before emergence of general anesthesia

Other: FiO2 0.5

Interventions

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%)

Intervention Group FiO2 0.5

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%)

Control Group FiO2=1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

University Hospital, Caen

Caen, 14033, France

Location

Related Publications (1)

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

  RESULT

MeSH Terms

Conditions

Pulmonary Atelectasis; Postoperative Complications; Hypoxia; Hyperoxia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Dr KAMGA TOTOUOM, MD

  Anesthesiologist

  PRINCIPAL INVESTIGATOR

• Pr HANOUZ, PhD

  Anesthesiologist

  STUDY DIRECTOR

• Dr BOUTROS, MD

  Anesthesiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 10, 2021
• Study Start: April 9, 2021
• Primary Completion: August 16, 2021
• Study Completion: August 16, 2021
• Last Updated: April 2, 2026

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)