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NOT YET RECRUITING
NCT07392918
NA

Esophageal Pressure-guided Personalized Recruitment Pressure During Pneumoperitoneum in Trendelenburg Position Laparoscopy

Sponsor: Ju Gao

View on ClinicalTrials.gov

Summary

This is a prospective, single-center, double-blind, randomized controlled trial designed to investigate the individual differences in recruitment efficacy and safety between personalized lung recruitment pressure based on esophageal pressure and conventional fixed lung recruitment pressure. The intervention involved calculating personalized lung recruitment pressure using inspiratory and expiratory esophageal pressures measured via a transnasal esophageal balloon catheter, which was then compared with a fixed pressure of 30 cmH₂O, each applied to maintain a single-cycle lung recruitment maneuver for 10 seconds. A total of 90 patients undergoing elective tracheal intubation under general anesthesia for head-down laparoscopic surgery were randomly assigned to either the experimental or control group. The primary outcome was post-recruitment lung compliance, and secondary outcomes included driving pressure, peak airway pressure (Ppeak), modified LUS score, gas exchange indices, hemodynamic parameters, length of stay in PACU after extubation, incidence of postoperative pulmonary complications (PPCs) on day 3 after surgery, and the rate of non-surgical antibiotic use.

Official title: Esophageal Pressure-guided Personalized Recruitment Pressure During Pneumoperitoneum in Trendelenburg Position Laparoscopy: A Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-02-20

Completion Date

2026-09-30

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

PROCEDURE

Esophageal Pressure

A transnasally placed esophageal balloon catheter was inserted. Following a positive-pressure occlusion test, end-inspiratory and end-expiratory esophageal pressures (Pes) were measured to estimate pleural pressure, thereby enabling the calculation of transpulmonary pressure in the non-dependent lung regions.Under conditions of homogeneous lung parenchyma, the physiological upper limit of transpulmonary pressure is 20 cmH₂O. To achieve this upper limit at end-inspiration in the non-dependent lung tissue, the lung recruitment pressure is calculated with the formula: P = 20 × ΔP / \[ΔP - (Pes\_insp - Pes\_exp)\], where the maximum pressure does not exceed 40 cmH₂O. Using the calculated pressure, a single-cycle recruitment maneuver is performed both 30 minutes after pneumoperitoneum establishment and before the end of surgery, each maintained for 10 seconds.

PROCEDURE

Lung Recruitment Maneuver

A single-cycle lung recruitment maneuver was performed at a fixed pressure of 30 cmH₂O for 10 seconds, both 30 minutes after pneumoperitoneum establishmentand immediately before the end of surgery.