Oxygenation IndexPhase 4NCT06359106
Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia
A Phase 4 study testing 80% Oxygen and 40% Oxygen in people with Oxygenation Index, run by China Medical University, China at 16 sites in China.
Trial summary
This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Oxygenation Index
- What is being tested?
- 80% Oxygen and 40% Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,176 participants
- Where
- 16 sitesChina
- Study dates
- 2 Jul 2024to 30 Jun 2026
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age not less than 65 years
- American Society of Anesthesiologists grades I-III
- No history of drug allergies or abnormal anesthesia.
- The duration of mechanical ventilation was expected to be more than 2 hours.
- Laparoscopic Gastrointestinal Surgery
- The preoperative oxygen saturation was not less than 94%.
- The patients will be planned to extubate in the operating room.
Who cannot join
- History of acute lung injury or acute respiratory distress syndrome (ARDS) within 3 months.
- Cardiac function Class IV (New York Heart Association classification)
- Chronic renal failure (renal cell filtration rate <30 ml min-11.73/m2), severe liver disease
- Patients with blurred consciousness and cognitive dysfunction
- Severe coagulation dysfunction.
- Without preoperative oxygen inhalation, blood oxygen level <94%, and severe pulmonary dysfunction
Show all 9Show fewer
- Patients with endotracheal tubes were admitted to the intensive care unit (ICU) after surgery.
- Body mass index (BMI) >30kg/m2
- Inability to complete the study
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Yun Wang
- Recruiting
Sichuan Provincial People's Hospital
Chendu
Qian Lei
- Recruiting
Chifeng Municipal Hospital
Chifeng
Jiannan Song
- Recruiting
Dalian Third People's Hospital
Dalian
Shiling Zhao
- Recruiting
First Affiliated Hospital, Dalian Medical University
Dalian
Yong Luan
- Recruiting
First Affiliated Hospital of Harbin Medical University
Harbin
Kun Wang
- Recruiting
Harbin Medical University Cancer Hospital
Harbin
Fei Han
- Recruiting
First Medical University and Shandong Provincial Qianfoshan Hospital
Jinan
Jianbo Wu
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming
Jianlin Shao
- Recruiting
Affiliated Hospital of Qingdao University
Qingdao
Wei Feng
- Recruiting
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
Wenfei Tan, M.D.,Ph.D, 024-83283100, winfieldtan@hotmail.com
- Recruiting
Liaoning Cancer Hospital and Institute
Shenyang
Zeqing Huang
- Recruiting
Shenzhen People's Hospita
Shenzhen
Chaoran Wu
- Recruiting
First Hospital of Hebei Medical University
Shijia Zhuang
Li Wang
- Recruiting
Second Hospital of Hebei Medical University
Shijia Zhuang
Lining Huang
- Recruiting
YANBIAN University Hospital（Yanbian Hospital）
Yanbian
Yongshan Nan
About this study
This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery.
Read the detailed description
This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery. the investigators planned to enroll 1098 subjects aged > 65 years for laparoscopic gastrointestinal surgery at 19 clinical trial centers in China, randomized in a 1:1 ratio, to use two inhaled oxygen concentrations during surgery. All patients will be performed via the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cmh2O, RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. The main outcome measure was the oxygenation index on the postoperative 48h. The secondary outcome measures were the 7-day postoperative pulmonary complications and 30-day mortality rates et al.
- Conditions
- Oxygenation Index
- Being tested
- 80% Oxygen, 40% Oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
80% OxygenDrug
After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute.
40% OxygenDrug
After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute.
| Study group | Role | What they receive |
|---|---|---|
| Control: 80% Oxygen | Placebo comparator | Before anesthesia induction, the participants inhaled 100% oxygen through the mask for 3 minutes. After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute. All patients will receive treatment through the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8mL/kg, positive end-expiratory pressure (PEEP), 6-8 cmH2O; RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. Blood will be collected for blood gas analysis within 48 hours after surgery. Receives: Drug: 80% Oxygen |
| Experimental: 40% Oxygen | Experimental | Before anesthesia induction, the participants inhaled 100% oxygen through the mask for 3 minutes. After successful anesthesia induction, FiO2 will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute. All patients will receive treatment through the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8mL/kg, positive end-expiratory pressure (PEEP), 6-8 cmH2O; RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. However, when intraoperative oxygen saturation is less than 94%, the manual lung recruitment maneuver will also be performed. Patients should transfer to 80% Oxygen group if intraoperative oxygen saturation less than 85%.Blood will be collected for blood gas analysis within 48 hours after surgery. Receives: Drug: 40% Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation Index
The primary outcome was the comparison of the oxygenation index between the two groups. Oxygenation index of acute lung injury is 200, and higher scores mean worse outcome.
Measured: On the postoperative 48th hour
Secondary outcomes (8)
pH value in blood gas analysis 48 hours after the operation
pH of blood gas analysis 48 hours after the operation
Measured: On the postoperative 48th hour
oxygen inhalation time
oxygen inhalation time
Measured: On the postoperative 48 hour
inspired oxygen concentration
inspired oxygen concentration
Measured: On the postoperative 48 hour
oxygen uptake rate
oxygen uptake rate
Measured: On the postoperative 48 hour
7 days pulmonary complications
7 days pulmonary complications
Measured: On the postoperative 7th day
30-day Mortality
30-day Mortality
Measured: On the postoperative 30th day
PaCO2 in blood gas analysis 48 hours after the operation
PaCO2 of blood gas analysis 48 hours after the operation
Measured: On the postoperative 48th hour
Lactic acid in blood gas analysis 48 hours after the operation
Lactic acid in blood gas analysis 48 hours after the operation
Measured: On the postoperative 48th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start2 Jul 2024
- Primary completion30 Jun 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxygenation IndexStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenfei Tan, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359106
- Sponsor's protocol ID
- 2024.3.1
- Status last verified
- Jan 2026
- First submitted
- 26 Mar 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Statistical Analysis Plan will be published
Publications
Zhang T, An Y, Zhao S, Han F, Huang L, Wang L, Wu J, Lei Q, Wang K, Shao J, Wang Y, Luan Y, Feng W, Song J, Huang Z, Wu C, Nan Y, Tang B, Sun X, Tan W. Effects of varying inhaled oxygen concentrations on lung function in older adult patients undergoing laparoscopic gastrointestinal surgery under general anesthesia: protocol of a prospective multicenter clinical study in China. Trials. 2026 Jan 23;27(1):139. doi: 10.1186/s13063-026-09471-3.
PubMed 41572351
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06359106
- Acronym / sponsor ID
- 2024.3.1
- Conditions
- Oxygenation Index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,176 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Apr 2024 (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.
This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery.
Detailed description
This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery. the investigators planned to enroll 1098 subjects aged > 65 years for laparoscopic gastrointestinal surgery at 19 clinical trial centers in China, randomized in a 1:1 ratio, to use two inhaled oxygen concentrations during surgery. All patients will be performed via the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cmh2O, RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. The main outcome measure was the oxygenation index on the postoperative 48h. The secondary outcome measures were the 7-day postoperative pulmonary complications and 30-day mortality rates et al.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: 80% Oxygen | Placebo comparator | Drug: 80% OxygenBefore anesthesia induction, the participants inhaled 100% oxygen through the mask for 3 minutes. After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute. All patients will receive treatment through the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8mL/kg, positive end-expiratory pressure (PEEP), 6-8 cmH2O; RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. Blood will be collected for blood gas analysis within 48 hours after surgery. |
| Experimental: 40% Oxygen | Experimental | Drug: 40% OxygenBefore anesthesia induction, the participants inhaled 100% oxygen through the mask for 3 minutes. After successful anesthesia induction, FiO2 will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute. All patients will receive treatment through the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8mL/kg, positive end-expiratory pressure (PEEP), 6-8 cmH2O; RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. However, when intraoperative oxygen saturation is less than 94%, the manual lung recruitment maneuver will also be performed. Patients should transfer to 80% Oxygen group if intraoperative oxygen saturation less than 85%.Blood will be collected for blood gas analysis within 48 hours after surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age not less than 65 years
- American Society of Anesthesiologists grades I-III
- No history of drug allergies or abnormal anesthesia.
- The duration of mechanical ventilation was expected to be more than 2 hours.
- Laparoscopic Gastrointestinal Surgery
Key exclusion criteria (9 listed)
- History of acute lung injury or acute respiratory distress syndrome (ARDS) within 3 months.
- Cardiac function Class IV (New York Heart Association classification)
- Chronic renal failure (renal cell filtration rate <30 ml min-11.73/m2), severe liver disease
- Patients with blurred consciousness and cognitive dysfunction
- Severe coagulation dysfunction.
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 |
|---|---|---|
| 80% OxygenAfter successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute. | Drug | Control: 80% Oxygen |
| 40% OxygenAfter successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute. | Drug | Experimental: 40% Oxygen |
Primary outcome
Oxygenation Index
Time frame: On the postoperative 48th hour
The primary outcome was the comparison of the oxygenation index between the two groups. Oxygenation index of acute lung injury is 200, and higher scores mean worse outcome.
8 secondary outcomes
pH value in blood gas analysis 48 hours after the operation
Time frame: On the postoperative 48th hour
oxygen inhalation time
Time frame: On the postoperative 48 hour
inspired oxygen concentration
Time frame: On the postoperative 48 hour
oxygen uptake rate
Time frame: On the postoperative 48 hour
7 days pulmonary complications
Time frame: On the postoperative 7th day
30-day Mortality
Time frame: On the postoperative 30th day
PaCO2 in blood gas analysis 48 hours after the operation
Time frame: On the postoperative 48th hour
Lactic acid in blood gas analysis 48 hours after the operation
Time frame: On the postoperative 48th hour
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 26 Jan 2026.
- Derived from this study: PubMed 41572351Zhang T, An Y, Zhao S, Han F, Huang L, Wang L, Wu J, Lei Q, Wang K, Shao J, Wang Y, Luan Y, Feng W, Song J, Huang Z, Wu C, Nan Y, Tang B, Sun X, Tan W. Effects of varying inhaled oxygen concentrations on lung function in older adult patients undergoing laparoscopic gastrointestinal surgery under general anesthesia: protocol of a prospective multicenter clinical study in China. Trials. 2026 Jan 23;27(1):139. doi: 10.1186/s13063-026-09471-3.
- Individual participant dataSharing planned: Yes. Study Protocol and Statistical Analysis Plan will be published
Related trials for Oxygenation Index
RecruitingObservational study
NIRS and BIS Monitoring During Cerebral Aneurysm Coiling
Cerebral Aneurysm
Recruiting
Transoral Nasal Cannula Oxygen Therapy for Mouth-Breathing Patients in the Postanesthesia Care Unit
Postoperative Hypoxemia
Not yet recruitingObservational study
Individualized vs Standard PEEP and Oxygen Reserve Index in Laparoscopic Hernia Surgery
Atelectasis, Perioperative Oxygenation
Recruiting
HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation
Procedural Sedation, Hypoxemia
Active, not recruitingObservational study
The CPR, Pre-hospital ECPR and Early Reperfusion Study: A Target Trial Emulation
Out of Hospital Cardiac Arrest, Extracorporeal Cardiopulmonary Resuscitation
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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 80% Oxygen and 40% Oxygen in people with Oxygenation Index, run by China Medical University, China at 16 sites 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tianhao Zhang, M.D. (+862483283100, zhth774176947@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation Index (time frame: On the postoperative 48th 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 NCT06359106, 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 26 Jan 2026.