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

Primary Purpose

Anesthesia, Atelectasis, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FiO2 0.5
FiO2 1
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring Post-anesthesia care unit, Extubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital, Caen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group FiO2=1

Intervention Group FiO2 0.5

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of emergence
Elapsed Time between cessation of sedation and extubation (minutes)
Primary Outcome Timing
Elapsed time between extubation and decrease of oxygen saturation (minutes)
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).
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
Corrective measures
Number of corrective measures (method and oxygen supply equipment used) after hypoxemia and proportion of success.
PACU length of stay
Length of stay in post-anesthesia care unit

Full Information

First Posted
April 23, 2021
Last Updated
November 2, 2021
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT04879290
Brief Title
Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit
Acronym
EXTUBO2
Official Title
Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit : a Monocentric Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
August 16, 2021 (Actual)
Study Completion Date
August 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Atelectasis, Postoperative Complications, Hypoxemia, Hyperoxia
Keywords
Post-anesthesia care unit, Extubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group FiO2=1
Arm Type
Active Comparator
Arm Description
FiO2 = 1 (100%) 10mn before emergence of general anesthesia
Arm Title
Intervention Group FiO2 0.5
Arm Type
Experimental
Arm Description
Fi02 = 0.5 (50%) 10mn before emergence of general anesthesia
Intervention Type
Other
Intervention Name(s)
FiO2 0.5
Intervention Description
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 Type
Other
Intervention Name(s)
FiO2 1
Intervention Description
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 Outcome Measure Information:
Title
Decrease of oxygen saturation
Description
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
Time Frame
Duration of stay in post-anesthesia care unit, approximately one hour
Secondary Outcome Measure Information:
Title
Duration of emergence
Description
Elapsed Time between cessation of sedation and extubation (minutes)
Time Frame
Up to one hour
Title
Primary Outcome Timing
Description
Elapsed time between extubation and decrease of oxygen saturation (minutes)
Time Frame
Up to one hour
Title
Number of risk factors
Description
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).
Time Frame
One hour
Title
Majored decrease of oxygen saturation
Description
Proportions of patients that present a decrease of 6 points of SpO2 after extubation compared to their baseline room air SpO2
Time Frame
One hour
Title
Corrective measures
Description
Number of corrective measures (method and oxygen supply equipment used) after hypoxemia and proportion of success.
Time Frame
One hour
Title
PACU length of stay
Description
Length of stay in post-anesthesia care unit
Time Frame
One hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr KAMGA TOTOUOM, MD
Organizational Affiliation
Anesthesiologist
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pr HANOUZ, PhD
Organizational Affiliation
Anesthesiologist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dr BOUTROS, MD
Organizational Affiliation
Anesthesiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Caen
City
Caen
ZIP/Postal Code
14033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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