AnesthesiaEXTUBO2NCT04879290
Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit
A study testing FiO2 0.5 and FiO2 1 in people with Anesthesia and Atelectasis, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Atelectasis, Postoperative Complications
- What is being tested?
- FiO2 0.5 and FiO2 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2021to 16 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Atelectasis, Postoperative Complications, Hypoxemia, Hyperoxia
- Being tested
- FiO2 0.5, FiO2 1
- Keywords
- Post-anesthesia care unit, Extubation
- Medical subject headings
- Pulmonary Atelectasis, Postoperative Complications, Hypoxia, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiO2 0.5Other
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 1Other
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%)
| Study group | Role | What they receive |
|---|---|---|
| Control Group FiO2=1 | Active comparator | FiO2 = 1 (100%) 10mn before emergence of general anesthesia Receives: Other: FiO2 1 |
| Intervention Group FiO2 0.5 | Experimental | Fi02 = 0.5 (50%) 10mn before emergence of general anesthesia Receives: Other: FiO2 0.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Duration of stay in post-anesthesia care unit, approximately one hour
Secondary outcomes (6)
Duration of emergence
Elapsed Time between cessation of sedation and extubation (minutes)
Measured: Up to one hour
Primary Outcome Timing
Elapsed time between extubation and decrease of oxygen saturation (minutes)
Measured: 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).
Measured: 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
Measured: One hour
Corrective measures
Number of corrective measures (method and oxygen supply equipment used) after hypoxemia and proportion of success.
Measured: One hour
PACU length of stay
Length of stay in post-anesthesia care unit
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start9 Apr 2021
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr KAMGA TOTOUOM, MD, Principal investigator, AnesthesiologistPr HANOUZ, PhD, Study director, AnesthesiologistDr BOUTROS, MD, Principal investigator, Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879290
- Sponsor's protocol ID
- 19-172
- Acronym
- EXTUBO2
- Status last verified
- Mar 2021
- First submitted
- 23 Apr 2021
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit : a Monocentric Randomized Trial
- ClinicalTrials.gov ID
- NCT04879290
- Acronym / sponsor ID
- EXTUBO2 / 19-172
- Conditions
- Anesthesia, Atelectasis, Postoperative Complications, Hypoxemia, Hyperoxia
- Keywords
- Post-anesthesia care unit, Extubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group FiO2=1 | Active comparator | Other: FiO2 1FiO2 = 1 (100%) 10mn before emergence of general anesthesia |
| Intervention Group FiO2 0.5 | Experimental | Other: FiO2 0.5Fi02 = 0.5 (50%) 10mn before emergence of general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiO2 0.5Ten 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%) | Other | Intervention Group FiO2 0.5 |
| FiO2 1Ten 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%) | Other | Control Group FiO2=1 |
Primary outcome
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
6 secondary outcomes
Duration of emergence
Time frame: Up to one hour
Primary Outcome Timing
Time frame: Up to one hour
Number of risk factors
Time frame: One hour
Majored decrease of oxygen saturation
Time frame: One hour
Corrective measures
Time frame: One hour
PACU length of stay
Time frame: One hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publicationComparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit (EXTUBO2) [abstract]. SFAR 2022 - Livre des résumés; 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr KAMGA TOTOUOM, MD principal investigator
Anesthesiologist
Pr HANOUZ, PhD study director
Anesthesiologist
Dr BOUTROS, MD principal investigator
Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FiO2 0.5 and FiO2 1 in people with Anesthesia and Atelectasis, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of oxygen saturation (time frame: Duration of stay in post-anesthesia care unit, approximately one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04879290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.