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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Pulmonary Atelectasis, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A: FiO2 = 30%

FiO2 of group A = 30%. If SPO2 \< 94%, improve FiO2; if FiO2≥40%, eliminate the patient.

Group Type EXPERIMENTAL

Fraction of inspiration O2(FiO2)

Intervention Type 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.

B: FiO2＝40%

FiO2＝40%

Group Type EXPERIMENTAL

Fraction of inspiration O2(FiO2)

Intervention Type 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.

C: FiO2＝60%

FiO2＝60%

Group Type EXPERIMENTAL

Fraction of inspiration O2(FiO2)

Intervention Type 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.

D: FiO2＝80%

FiO2＝80%

Group Type EXPERIMENTAL

Fraction of inspiration O2(FiO2)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No