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NCT Number: NCT06746181

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

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.

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Key information

Conditions

Pulmonary Atelectasis, Postoperative Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fraction of inspiration O2(FiO2)

Behavioral

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.

Primary outcomes

  1. Duration of improvement in lung compliance

    Time frame: during the surgery

    Time to return to baseline levels of lung compliance after lung recruitment

Secondary outcomes

  1. Incidence of hypoxemia during PACU

    Time frame: From the time of entry to the PACU to the time of exit from the PACU

  2. Incidence of pulmonary atelectasis at the end of surgery

    Time frame: Surgery complete, extubation immediate

  3. Incidence of pulmonary complications within 3 days after surgery

    Time frame: From the end of surgery to 3 days after surgery

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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