HypoxemiaNCT07293286
Effect of Different Oxygen Concentrations Before Extubation After General Anesthesia on Hypoxemia After Extubation in Post-anesthesia Care Unit
A study testing 100% oxygen concentration inhaled and 30% oxygen concentration inhaled in people with Hypoxemia, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Before extubation during the anesthesia recovery period, 100% oxygen is routinely inhaled to increase the oxygen reserves, maximizing the time window for anesthesiologists to adjust strategies when they encounter hypoxemia after extubation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- 100% oxygen concentration inhaled and 30% oxygen concentration inhaled
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years old, scheduled for elective abdominal surgery in general anesthesia with endotracheal intubation; ASA I-III grade; cardiac function 1-2 grade; 18 kg/m2 < BMI < 28 kg/m2; Preoperative SpO2 ≥ 94% without oxygen supplementation at rest; pre-anesthesia assessment shows no difficult airway, no difficulty with mask ventilation, no difficulty in intubation during tracheal insertion, and no difficulty in extubation as expected.
Who cannot join
- Respiratory infection recently, or atelectasis, inflammation, fibrosis, or pleural effusion by chest CT preoperatively.
- History thoracic surgery and fractures of the sternum or ribs, chest deformity, difficulty in raising both upper limbs, or scoliosis.
- High risk of reflux aspiration. Severe hepatic or renal dysfunction (e.g., Child-Pugh class C liver disease, or requiring dialysis).
- Limb movement disorders. Mask ventilation or intubation difficulty during anesthesia induction. Occurrence of severe allergy, massive bleeding, suspected pulmonary embolism, pulmonary edema, myocardial injury, or cardiopulmonary arrest during surgery.
- Currently participating in other clinical studies, which may have an impact on this study.
- Inability to cooperate well for mental disorder, or hypophrenia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
Sanqing Jin, +86 13719366863, sanqingjin@hotmail.com
About this study
Official title: Effect of Different Oxygen Concentrations During the Recovery Period Before Extubation After General Anesthesia on Hypoxemia After Extubation in Post-anesthesia Care Unit
Before extubation during the anesthesia recovery period, 100% oxygen is routinely inhaled to increase the oxygen reserves, maximizing the time window for anesthesiologists to adjust strategies when they encounter hypoxemia after extubation.
However, even inhaling a short period of pure oxygen can cause absorptive atelectasis, and may even impair the effectiveness of intraoperative protective ventilation measures continuing to post-operative period. The purpose of this study is to determine whether 30% oxygen before extubation after abdominal surgery could reduce hypoxemia incidence after extubation during the recovery period or not, compared to 100% oxygen. 590 patients scheduled to abdominal surgeries, will be randomly assigned to receive 30% or 100% oxygen concentration from the end of surgery to extubation after general anesthesia in the post-anesthesia care unit. The incidence of hypoxemia (SpO2 < 90%) from extubation to leaving the post-anesthesia care unit (PACU) is the primary outcome.
- Conditions
- Hypoxemia
- Being tested
- 100% oxygen concentration inhaled, 30% oxygen concentration inhaled
- Keywords
- hypoxemia, oxygen concentration, atelectasis
- Medical subject headings
- Hypoxia, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% oxygen concentration inhaledOther
Oxygen concentration inhaled from the end of surgery to tracheal extubation after general anesthesia in the recovery period is 100%.
30% oxygen concentration inhaledOther
Oxygen concentration inhaled from the end of surgery to tracheal extubation after general anesthesia in the recovery period is 30%.
| Study group | Role | What they receive |
|---|---|---|
| Control group : 100% oxygen concentration | Active comparator | Patients will inhale 100% oxygen from the end of surgery to tracheal extubation in the recovery period. Receives: Other: 100% oxygen concentration inhaled |
| Experimental group: 30% oxygen concentration | Experimental | Patients will inhale 30% oxygen from the end of surgery to extubation in the recovery period. Receives: Other: 30% oxygen concentration inhaled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxemia
Measured: At the day of surgery from tracheal extubation to leaving the post-anesthesia care unit
Secondary outcomes (10)
Incidence of post operative pulmonary-related complications
Measured: Within 7 days after surgery
Incidence of severe hypoxemia
Measured: At the day of surgery from tracheal extubation to leaving the post-anesthesia care unit
Arterial partial pressure of oxygen (PaO2)
Measured: At the day of surgery after tracheal extubation in the post-anesthesia care unit
Score of lung ultrasound
The score of lung ultrasound ranges from 0 to 36, and a higher score means a worse ventilation.
Measured: At the day of surgery after tracheal extubation in the post-anesthesia care unit
Area of atelectasis shown on chest CT
Measured: At the day of surgery after tracheal extubation
Number of patients unplanned transfers to the ICU
Measured: 30 days after surgery
Length of postoperative stay
Measured: At hospital discharge
Number of patients return to the hospital after discharge
Measured: 30 days after surgery
Number of deaths
Measured: 30 days after surgery
Number of patients with important organ disfunction after surgery, including arrhythmia, acute myocardial injury, heart failure, renal function injury, liver function injury, and cerebrovascular accident.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SanQing Jin, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293286
- Sponsor's protocol ID
- 2025ZSLYSC-630
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Oxygen Concentrations During the Recovery Period Before Extubation After General Anesthesia on Hypoxemia After Extubation in Post-anesthesia Care Unit
- ClinicalTrials.gov ID
- NCT07293286
- Acronym / sponsor ID
- 2025ZSLYSC-630
- Conditions
- Hypoxemia
- Keywords
- hypoxemia, oxygen concentration, atelectasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Dec 2025 (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.
Before extubation during the anesthesia recovery period, 100% oxygen is routinely inhaled to increase the oxygen reserves, maximizing the time window for anesthesiologists to adjust strategies when they encounter hypoxemia after extubation.
However, even inhaling a short period of pure oxygen can cause absorptive atelectasis, and may even impair the effectiveness of intraoperative protective ventilation measures continuing to post-operative period. The purpose of this study is to determine whether 30% oxygen before extubation after abdominal surgery could reduce hypoxemia incidence after extubation during the recovery period or not, compared to 100% oxygen. 590 patients scheduled to abdominal surgeries, will be randomly assigned to receive 30% or 100% oxygen concentration from the end of surgery to extubation after general anesthesia in the post-anesthesia care unit. The incidence of hypoxemia (SpO2 < 90%) from extubation to leaving the post-anesthesia care unit (PACU) is the primary outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group : 100% oxygen concentration | Active comparator | Other: 100% oxygen concentration inhaledPatients will inhale 100% oxygen from the end of surgery to tracheal extubation in the recovery period. |
| Experimental group: 30% oxygen concentration | Experimental | Other: 30% oxygen concentration inhaledPatients will inhale 30% oxygen from the end of surgery to extubation in the recovery period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-65 years old, scheduled for elective abdominal surgery in general anesthesia with endotracheal intubation; ASA I-III grade; cardiac function 1-2 grade; 18 kg/m2 < BMI < 28 kg/m2; Preoperative SpO2 ≥ 94% without oxygen supplementation at rest; pre-anesthesia assessment shows no difficult airway, no difficulty with mask ventilation, no difficulty in intubation during tracheal insertion, and no difficulty in extubation as expected.
Key exclusion criteria (6 listed)
- Respiratory infection recently, or atelectasis, inflammation, fibrosis, or pleural effusion by chest CT preoperatively.
- History thoracic surgery and fractures of the sternum or ribs, chest deformity, difficulty in raising both upper limbs, or scoliosis.
- High risk of reflux aspiration. Severe hepatic or renal dysfunction (e.g., Child-Pugh class C liver disease, or requiring dialysis).
- Limb movement disorders. Mask ventilation or intubation difficulty during anesthesia induction. Occurrence of severe allergy, massive bleeding, suspected pulmonary embolism, pulmonary edema, myocardial injury, or cardiopulmonary arrest during surgery.
- Currently participating in other clinical studies, which may have an impact on this study.
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 |
|---|---|---|
| 100% oxygen concentration inhaledOxygen concentration inhaled from the end of surgery to tracheal extubation after general anesthesia in the recovery period is 100%. | Other | Control group : 100% oxygen concentration |
| 30% oxygen concentration inhaledOxygen concentration inhaled from the end of surgery to tracheal extubation after general anesthesia in the recovery period is 30%. | Other | Experimental group: 30% oxygen concentration |
Primary outcome
Incidence of hypoxemia
Time frame: At the day of surgery from tracheal extubation to leaving the post-anesthesia care unit
10 secondary outcomes
Incidence of post operative pulmonary-related complications
Time frame: Within 7 days after surgery
Incidence of severe hypoxemia
Time frame: At the day of surgery from tracheal extubation to leaving the post-anesthesia care unit
Arterial partial pressure of oxygen (PaO2)
Time frame: At the day of surgery after tracheal extubation in the post-anesthesia care unit
Score of lung ultrasound
Time frame: At the day of surgery after tracheal extubation in the post-anesthesia care unit
Area of atelectasis shown on chest CT
Time frame: At the day of surgery after tracheal extubation
Number of patients unplanned transfers to the ICU
Time frame: 30 days after surgery
Length of postoperative stay
Time frame: At hospital discharge
Number of patients return to the hospital after discharge
Time frame: 30 days after surgery
Number of deaths
Time frame: 30 days after surgery
Number of patients with important organ disfunction after surgery, including arrhythmia, acute myocardial injury, heart failure, renal function injury, liver function injury, and cerebrovascular accident.
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100% oxygen concentration inhaled and 30% oxygen concentration inhaled in people with Hypoxemia, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 Dec 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanqing Jin (+86 13719366863, sanqingjin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxemia (time frame: At the day of surgery from tracheal extubation to leaving the post-anesthesia care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2025.