Pulmonary Atelectasis, PostoperativeNCT06746181
Effect of Different Inspired Oxygen Concentrations on Intraoperative Recruitment Outcomes in Patients Undergoing Abdominal Surgery
A study testing Fraction of inspiration O2(FiO2) in people with Pulmonary Atelectasis, Postoperative, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
This study intends to evaluate the effect of different inhaled oxygen concentrations on the effect of lung recruitment in patients undergoing abdominal surgery. During perioperative mechanical ventilation, higher FiO2 is usually given to prevent the occurrence of hypoxemia, but there are no conclusions about the… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pulmonary Atelectasis, Postoperative
- What is being tested?
- Fraction of inspiration O2(FiO2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 30 Jan 2026
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status classification: I or II.
- Adults aged 18 to 64 years, regardless of gender.
- BMI between 18 kg/m² and 25 kg/m².
- Patients undergoing elective abdominal surgery under general anesthesia.
- Patients with estimated operating time ≥1.5h and intraoperative bleeding ≤500ml.
- Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.
Who cannot join
- Previous thoracic surgery.
- Chest X-ray or CT suggestive of pneumothorax or alveoli.
- Lung disease: chronic bronchitis, asthma, moderate to severe obstructive ventilatory dysfunction.
- Preoperative pulse oxygen saturation (SpO2) <90% on breathing air or SpO2 <95% on oxygen.
- Contraindications to lung reanimation: high intracranial pressure, hypovolemic shock, right heart failure.
- Severe heart disease (New York Heart Association, NYHA class III or IV.
- Acute coronary syndrome or sustained ventricular tachyarrhythmia).
- Participation in other interventional studies or refusal of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
This study intends to evaluate the effect of different inhaled oxygen concentrations on the effect of lung recruitment in patients undergoing abdominal surgery. During perioperative mechanical ventilation, higher FiO2 is usually given to prevent the occurrence of hypoxemia, but there are no conclusions about the setting of optimal FiO2 during surgery.
Dynamic pulmonary compliance enables real-time monitoring of alveolar changes and is used to assess pulmonary function in intraoperative patients. The value of compliance represents the number of air-containing alveoli; the more alveoli are trapped, the less air-containing tissue there is and the lower the compliance. Lung recruitment, as part of a lung-protective ventilation strategy, is effective in opening alveoli and improving oxygenation. This single-center, randomized controlled trial will explore the optimal inspired oxygen concentration that allows patients to benefit from lung recruitment and the duration of improvement in lung compliance after lung recruitment.
- Conditions
- Pulmonary Atelectasis, Postoperative
- Being tested
- Fraction of inspiration O2(FiO2)
- Keywords
- Inhaled oxygen concentration, lung recruitment
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fraction of inspiration O2(FiO2)Behavioural
After the patient was admitted to the room, anesthesia induction was performed after pre-oxygenation for 3 minutes. Tracheal intubation was carried out once the medication had fully taken effect. After the surgery began, the inspired oxygen concentration was adjusted for each group. The first lung recruitment maneuver was performed 10 minutes later, and subsequent lung recruitment maneuvers were conducted when pulmonary compliance returned to baseline levels. This process was repeated, with all patients undergoing one final lung recruitment maneuver immediately at the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| A: FiO2 = 30% | Experimental | FiO2 of group A = 30%. If SPO2 < 94%, improve FiO2; if FiO2≥40%, eliminate the patient. Receives: Behavioral: Fraction of inspiration O2(FiO2) |
| B: FiO2＝40% | Experimental | FiO2＝40% Receives: Behavioral: Fraction of inspiration O2(FiO2) |
| C: FiO2＝60% | Experimental | FiO2＝60% Receives: Behavioral: Fraction of inspiration O2(FiO2) |
| D: FiO2＝80% | Experimental | FiO2＝80% Receives: Behavioral: Fraction of inspiration O2(FiO2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of improvement in lung compliance
Time to return to baseline levels of lung compliance after lung recruitment
Measured: during the surgery
Secondary outcomes (3)
Incidence of hypoxemia during PACU
Measured: From the time of entry to the PACU to the time of exit from the PACU
Incidence of pulmonary atelectasis at the end of surgery
Measured: Surgery complete, extubation immediate
Incidence of pulmonary complications within 3 days after surgery
Measured: From the end of surgery to 3 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 posted24 Dec 2024
- Study start1 Apr 2025
- Primary completion29 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Atelectasis, PostoperativeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Gao, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746181
- Sponsor's protocol ID
- 2024ky310
- Status last verified
- Feb 2026
- First submitted
- 17 Dec 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared. Data will include demographic characteristics, procedural details, and outcome measures. Access will be granted to qualified researchers upon request via a secure data repository.
Publications
Edmark L, Ostberg E, Scheer H, Wallquist W, Hedenstierna G, Zetterstrom H. Preserved oxygenation in obese patients receiving protective ventilation during laparoscopic surgery: a randomized controlled study. Acta Anaesthesiol Scand. 2016 Jan;60(1):26-35. doi: 10.1111/aas.12588. Epub 2015 Aug 3.
PubMed 26235391Andrade FSRM, Ambrosio AM, Rodrigues RR, Facco LL, Goncalves LA, Garcia Filho SG, Dos Santos RT, Rossetto TC, Pereira MAA, Fantoni DT. The optimal PEEP after alveolar recruitment maneuver assessed by electrical impedance tomography in healthy horses. Front Vet Sci. 2022 Dec 9;9:1024088. doi: 10.3389/fvets.2022.1024088. eCollection 2022.
PubMed 36570501Lee JH, Choi S, Ji SH, Jang YE, Kim EH, Kim HS, Kim JT. Effect of an ultrasound-guided lung recruitment manoeuvre on postoperative atelectasis in children: A randomised controlled trial. Eur J Anaesthesiol. 2020 Aug;37(8):719-727. doi: 10.1097/EJA.0000000000001175.
PubMed 32068572Wu XZ, Xia HM, Zhang P, Li L, Hu QH, Guo SP, Li TY. Effects of ultrasound-guided alveolar recruitment manoeuvres compared with sustained inflation or no recruitment manoeuvres on atelectasis in laparoscopic gynaecological surgery as assessed by ultrasonography: a randomized clinical trial. BMC Anesthesiol. 2022 Aug 16;22(1):261. doi: 10.1186/s12871-022-01798-z.
PubMed 35974310Neira VM, Kovesi T, Guerra L, Campos M, Barrowman N, Splinter WM. The impact of pneumoperitoneum and Trendelenburg positioning on respiratory system mechanics during laparoscopic pelvic surgery in children: a prospective observational study. Can J Anaesth. 2015 Jul;62(7):798-806. doi: 10.1007/s12630-015-0369-0. Epub 2015 Apr 23.
PubMed 25902890Young CC, Harris EM, Vacchiano C, Bodnar S, Bukowy B, Elliott RRD, Migliarese J, Ragains C, Trethewey B, Woodward A, Gama de Abreu M, Girard M, Futier E, Mulier JP, Pelosi P, Sprung J. Lung-protective ventilation for the surgical patient: international expert panel-based consensus recommendations. Br J Anaesth. 2019 Dec;123(6):898-913. doi: 10.1016/j.bja.2019.08.017. Epub 2019 Oct 3.
PubMed 31587835
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Inspired Oxygen Concentrations on Intraoperative Recruitment Outcomes in Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06746181
- Acronym / sponsor ID
- 2024ky310
- Conditions
- Pulmonary Atelectasis, Postoperative
- Keywords
- Inhaled oxygen concentration, lung recruitment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 24 Dec 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 study intends to evaluate the effect of different inhaled oxygen concentrations on the effect of lung recruitment in patients undergoing abdominal surgery. During perioperative mechanical ventilation, higher FiO2 is usually given to prevent the occurrence of hypoxemia, but there are no conclusions about the setting of optimal FiO2 during surgery.
Dynamic pulmonary compliance enables real-time monitoring of alveolar changes and is used to assess pulmonary function in intraoperative patients. The value of compliance represents the number of air-containing alveoli; the more alveoli are trapped, the less air-containing tissue there is and the lower the compliance. Lung recruitment, as part of a lung-protective ventilation strategy, is effective in opening alveoli and improving oxygenation. This single-center, randomized controlled trial will explore the optimal inspired oxygen concentration that allows patients to benefit from lung recruitment and the duration of improvement in lung compliance after lung recruitment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: FiO2 = 30% | Experimental | Behavioral: Fraction of inspiration O2(FiO2)FiO2 of group A = 30%. If SPO2 < 94%, improve FiO2; if FiO2≥40%, eliminate the patient. |
| B: FiO2＝40% | Experimental | Behavioral: Fraction of inspiration O2(FiO2)FiO2＝40% |
| C: FiO2＝60% | Experimental | Behavioral: Fraction of inspiration O2(FiO2)FiO2＝60% |
| D: FiO2＝80% | Experimental | Behavioral: Fraction of inspiration O2(FiO2)FiO2＝80% |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ASA physical status classification: I or II.
- Adults aged 18 to 64 years, regardless of gender.
- BMI between 18 kg/m² and 25 kg/m².
- Patients undergoing elective abdominal surgery under general anesthesia.
- Patients with estimated operating time ≥1.5h and intraoperative bleeding ≤500ml.
Key exclusion criteria (8 listed)
- Previous thoracic surgery.
- Chest X-ray or CT suggestive of pneumothorax or alveoli.
- Lung disease: chronic bronchitis, asthma, moderate to severe obstructive ventilatory dysfunction.
- Preoperative pulse oxygen saturation (SpO2) <90% on breathing air or SpO2 <95% on oxygen.
- Contraindications to lung reanimation: high intracranial pressure, hypovolemic shock, right heart failure.
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 |
|---|---|---|
| Fraction of inspiration O2(FiO2)After the patient was admitted to the room, anesthesia induction was performed after pre-oxygenation for 3 minutes. Tracheal intubation was carried out once the medication had fully taken effect. After the surgery began, the inspired oxygen concentration was adjusted for each group. The first lung recruitment maneuver was performed 10 minutes later, and subsequent lung recruitment maneuvers were conducted when pulmonary compliance returned to baseline levels. This process was repeated, with all patients undergoing one final lung recruitment maneuver immediately at the end of the surgery. | Behavioural | A: FiO2 = 30%, B: FiO2＝40%, C: FiO2＝60%, D: FiO2＝80% |
Primary outcome
Duration of improvement in lung compliance
Time frame: during the surgery
Time to return to baseline levels of lung compliance after lung recruitment
3 secondary outcomes
Incidence of hypoxemia during PACU
Time frame: From the time of entry to the PACU to the time of exit from the PACU
Incidence of pulmonary atelectasis at the end of surgery
Time frame: Surgery complete, extubation immediate
Incidence of pulmonary complications within 3 days after surgery
Time frame: From the end of surgery to 3 days after surgery
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 24 Feb 2026.
- Results publication: PubMed 26235391Edmark L, Ostberg E, Scheer H, Wallquist W, Hedenstierna G, Zetterstrom H. Preserved oxygenation in obese patients receiving protective ventilation during laparoscopic surgery: a randomized controlled study. Acta Anaesthesiol Scand. 2016 Jan;60(1):26-35. doi: 10.1111/aas.12588. Epub 2015 Aug 3.
- Results publication: PubMed 36570501Andrade FSRM, Ambrosio AM, Rodrigues RR, Facco LL, Goncalves LA, Garcia Filho SG, Dos Santos RT, Rossetto TC, Pereira MAA, Fantoni DT. The optimal PEEP after alveolar recruitment maneuver assessed by electrical impedance tomography in healthy horses. Front Vet Sci. 2022 Dec 9;9:1024088. doi: 10.3389/fvets.2022.1024088. eCollection 2022.
- Results publication: PubMed 32068572Lee JH, Choi S, Ji SH, Jang YE, Kim EH, Kim HS, Kim JT. Effect of an ultrasound-guided lung recruitment manoeuvre on postoperative atelectasis in children: A randomised controlled trial. Eur J Anaesthesiol. 2020 Aug;37(8):719-727. doi: 10.1097/EJA.0000000000001175.
- Results publication: PubMed 35974310Wu XZ, Xia HM, Zhang P, Li L, Hu QH, Guo SP, Li TY. Effects of ultrasound-guided alveolar recruitment manoeuvres compared with sustained inflation or no recruitment manoeuvres on atelectasis in laparoscopic gynaecological surgery as assessed by ultrasonography: a randomized clinical trial. BMC Anesthesiol. 2022 Aug 16;22(1):261. doi: 10.1186/s12871-022-01798-z.
- Results publication: PubMed 25902890Neira VM, Kovesi T, Guerra L, Campos M, Barrowman N, Splinter WM. The impact of pneumoperitoneum and Trendelenburg positioning on respiratory system mechanics during laparoscopic pelvic surgery in children: a prospective observational study. Can J Anaesth. 2015 Jul;62(7):798-806. doi: 10.1007/s12630-015-0369-0. Epub 2015 Apr 23.
- Results publication: PubMed 31587835Young CC, Harris EM, Vacchiano C, Bodnar S, Bukowy B, Elliott RRD, Migliarese J, Ragains C, Trethewey B, Woodward A, Gama de Abreu M, Girard M, Futier E, Mulier JP, Pelosi P, Sprung J. Lung-protective ventilation for the surgical patient: international expert panel-based consensus recommendations. Br J Anaesth. 2019 Dec;123(6):898-913. doi: 10.1016/j.bja.2019.08.017. Epub 2019 Oct 3.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared. Data will include demographic characteristics, procedural details, and outcome measures. Access will be granted to qualified researchers upon request via a secure data repository.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fraction of inspiration O2(FiO2) in people with Pulmonary Atelectasis, Postoperative, run by Northern Jiangsu People's Hospital 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 6 inclusion and 8 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 24 Feb 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 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?
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?
Duration of improvement in lung compliance (time frame: during the surgery). 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 NCT06746181, which also lists 6 linked publications.
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 24 Feb 2026.