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Effect of Different Inspired Oxygen Concentrations on Intraoperative Recruitment Outcomes in Patients Undergoing Abdominal Surgery

Effect of Different Inspired Oxygen Concentrations on Intraoperative Recruitment Outcomes in Patients Undergoing Abdominal Surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06746181
Enrollment
95
Registered
2024-12-24
Start date
2025-04-01
Completion date
2026-01-30
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Atelectasis, Postoperative

Keywords

Inhaled oxygen concentration, lung recruitment

Brief 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 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.

Interventions

BEHAVIORALFraction 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.

Sponsors

Northern Jiangsu People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Duration of improvement in lung complianceduring the surgeryTime to return to baseline levels of lung compliance after lung recruitment

Secondary

MeasureTime frame
Incidence of hypoxemia during PACUFrom the time of entry to the PACU to the time of exit from the PACU
Incidence of pulmonary atelectasis at the end of surgerySurgery complete, extubation immediate
Incidence of pulmonary complications within 3 days after surgeryFrom the end of surgery to 3 days after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026