Optimizing lung ventilation during abdominal surgery

Protective Lung Ventilation Procedure During General Anesthesia Reduces the Incidence of Pulmonary Complications After Abdominal Surgery, Possibly

This study tests whether a special way of helping people breathe during abdominal surgery can reduce lung problems after the operation compared to the usual method.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Croatian Health Insurance Fund (other gov)
• Locations: 1 site (Zabok)
• Trial ID: NCT06282003 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of protective lung ventilation compared to conventional ventilation during general anesthesia in patients undergoing abdominal surgery. It involves a randomized controlled design with two groups: one receiving conventional ventilation and the other receiving a protective ventilation strategy aimed at reducing postoperative pulmonary complications. The study focuses on patients classified as ASA 1 or ASA 2, ensuring they have normal heart and lung function and meet specific health criteria. The goal is to better understand how different ventilation strategies impact respiratory function during and after surgery.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-65 undergoing planned medial laparotomy for colorectal cancer with no significant comorbidities.

Not a fit: Patients with severe systemic diseases or significant respiratory issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of respiratory complications following abdominal surgery.

How similar studies have performed: Previous studies have shown promising results with protective ventilation strategies, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* the inclusion criteria were as follows:
* subject status according to the American Society of Anesthesiologists Association classification
* ASA 1 (normal healthy patients, i.e. patients without associated comorbidities) or ASA 2 (patients with mild systemic disease, such as well-controlled hypertension), normal heart and lung function, both sexes,
* non-smokers, normal X-ray findings for heart and lungs,
* age 18-65 years,
* planned operation of medial laparotomy for colorectal cancer with a minimum duration of anesthesia of at least one hour,
* signed informed consent.
* In the case of hypertension in ASA 2 patients enrolled in the study, by examining the self-monitoring diary for the past three months (as described in Gropper et al., 2019), there was no increase in systolic pressure more than 20 mmHg from the average daily value and no increase in diastolic arterial pressure more than 10 mmHg from the average daily value.
* In the case of diabetes type II in ASA 2 patients enrolled in the study, the HbA1c values were not higher than 7% while taking oral hypoglycemic drugs and having a regulated diet. The patients enrolled also had no complications or episodes of hypoglycemia in the past three months, as described by Gropper et al., 2019.
* In the case of thyroid disease in ASA 2 patients enrolled in the study, values of TSH, fT3, and fT4 in the period up to 6 months since the last examination were normal.

Exclusion Criteria:

* ASA 4 status
* terminal renal illness
* cardiac status NYHA III i NYHA IV
* at home oxygenotherapy during 16 hours

Where this trial is running

Zabok

• General hospital Zabok — Zabok, Croatia (RECRUITING)

Study contacts

• Study coordinator: Maša Kontić, Medical Doctor; a

Conditions: Well-Being, Psychological, general anaesthesia, intraoperative complications, postoperative complications, lung recruitment procedure therapeutic positive-pressure ventilation