Lung Ultrasound Evaluation of the Effects of PEEP and Recruitment Strategies Adjusted for Intraoperative Dynamic Compliance on Postoperative Respiratory Complications in Obese Patients Planned for Laparoscopic Surgery

NCT06994780 | Active Not Recruiting DMC

• 1 other identifier: Marmara üniversitesi
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to investigate the effects of the personalized application of respiratory pressures applied to patients undergoing laparoscopic bariatric surgery when they are connected to a ventilator under general anesthesia, on the postoperative period. The effects of the ventilation practices that are fixed in routine practice and revised according to various variables during the surgery during artificial respiration after intubation under general anesthesia will be examined with ultrasonography. No change will be made to the routine anesthesia practice for this purpose, the pressure values in the ventilator under general anesthesia will be adjusted during the surgery within the framework of the values used in anesthesia practice. After the surgery, the lung area will be examined with ultrasound in the recovery unit and the findings will be recorded. This study does not have any undesirable effects or risks. This study does not include any interventional procedures.

Conditions

Obesity; Postoperative Bariatric Surgery; Laparoscopic Surgery; Individualized PEEP Treatment Strategy

Keywords

individualized PEEP treatment surgery; obesity; postoperative pulmonary complications; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Modified lung ultrasound score

  Each hemithorax will be divided into 6 regions by 3 vertical lines from the anterior axillary, parasternal and posterior axillary lines; 2 horizontal imaginary lines 1 cm above the nipple and at the level of the diaphragm. Each region will be evaluated in terms of lung sliding motion, A lines, B lines, consolidation, air bronchograms, pleural effusion and pneumothorax, and the total score calculated for 12 regions will be recorded and compared using the scoring system defined by Monastesse et al (2017).

  At the end of the surgery, a modified lung ultrasonography will be performed in the recovery unit.

Secondary Outcomes (3)

• postoperative pulmonary complications

  postoperative 3 days

• hospitalization day

  postoperative day 1-8

• postoperatif blood result

  postoperative day 1 to 8

Study Arms (2)

group PEEP8

NO INTERVENTION

The first group (group PEEP8) will be applied with a fixed PEEP of 8cmH20 throughout the intraoperative period by adjusting the tidal volume of 6-8 ml/kg according to the ideal weight, and a manual recruitment maneuver (with a pressure of 30 cmH2O for 40 seconds) will be applied after the pneumoperitoneum is terminated.

group DC

EXPERIMENTAL

The second group (Group DC) will be ventilated in VCV mode again and a tidal volume of 6-8 ml/kg will be given according to their ideal weight. The PEEP value at which the highest compliance value determined in the anesthesia device is obtained will be adjusted. In this group, PEEP titration will be repeated during pneumoperitoneum and skin closure. While PEEP titration is applied to the patients, a recruitment maneuver will also be applied. In this maneuver, PEEP will be increased at 2-minute intervals with a maximum peak pressure of 45 cmH2O and a driving pressure of 15 cmH2O, and when the target is reached, it will be decreased and the PEEP value will be adjusted at the value at which the highest compliance is obtained.

Procedure: dynamic compliance guided PEEP titration

Interventions

dynamic compliance guided PEEP titration PROCEDURE

In order to find the individualized optimal PEEP value, PEEP will be increased at 2-minute intervals with a maximum peak pressure of 45 cmH2O and a driving pressure of 15 cmH2O. Recruitment will be performed. When the target is reached, the PEEP value will be adjusted to the value at which the highest dynamic compliance is achieved by decreasing it.

group DC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients over the age of 18, with a body mass index of 35 and above, and who are scheduled for laparoscopic bariatric surgery will be included in our study.

You may not qualify if:

• Patients with advanced COPD,
• Patients with a history of pneumothorax,
• Patients with lung bullae,
• Patients who have undergone thoracic surgery,
• Patients with a diagnosis of major cardiac disease (valve diseases, heart failure, systolic dysfunction),
• Patients with severe respiratory failure,
• Patients with previous pulmonary surgery will not be included in the study.

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (2)

Marmara University Pendik Training and Reseach Hospital

Istanbul, Pendik, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Istanbul, pendik, Turkey (Türkiye)

Location

Related Links

• This study shows that LUS is highly feasible and frequently detects postoperative pulmonary complications after major abdominal surgery.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: this study is a double-blind study. the patient and the specialist physician performing the postoperative lung ultrasound will not know which group the patient is in.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dilara Göçmen, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 29, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)