Clinical trial NCT06746181: Effect of Different Inspired Oxygen Concentrations on Intraoperative Recruitment Outcomes in Patients Undergoing Abdominal Surgery
Official title: Effect of Different Inspired Oxygen Concentrations on Intraoperative Recruitment Outcomes in Patients Undergoing Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Atelectasis, Postoperative
Keywords: Inhaled oxygen concentration
lung recruitment
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Duration of improvement in lung compliance
timeFrame: during the surgery
Secondary outcomes:
measure: Incidence of hypoxemia during PACU
timeFrame: From the time of entry to the PACU to the time of exit from the PACU
measure: Incidence of pulmonary atelectasis at the end of surgery
timeFrame: Surgery complete, extubation immediate
measure: Incidence of pulmonary complications within 3 days after surgery
timeFrame: From the end of surgery to 3 days after surgery
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
References:
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citation: Young 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.