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

NCT07392918 | Not Yet Recruiting

• 1 other identifier: 2026KY021
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Esophageal Pressure; Recruitment Maneuver

Keywords

Esophageal Pressure; Recruitment Maneuver; Trendelenburg Position; Laparoscope

Outcome Measures

Primary Outcomes (1)

• Lung Compliance

  Lung compliance refers to the change in lung volume per unit change in pressure. It was obtained immediately after the lung recruitment maneuver by recording the value displayed on the anesthesia machine.

  From the establishment of pneumoperitoneum until the end of surgery.

Study Arms (2)

Personalized Lung Recruitment Pressure Group

EXPERIMENTAL

The inspiratory and expiratory esophageal pressures (Pes) are measured using a transnasal esophageal balloon catheter to estimate pleural pressure, thereby calculating the 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(P) is calculated with the formula: P = 20 × ΔP / \[ΔP - (Pes\_insp - Pes\_exp)\], where the maximum pressure does not exceed 40 cmH₂O;ΔP is Driving Pressure. 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: Esophageal Pressure

Fixed Lung Recruitment Pressure Group

OTHER

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

Procedure: Lung Recruitment Maneuver

Interventions

Esophageal Pressure PROCEDURE

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.

Also known as: Transpulmonary Pressure, Pleural Pressure

Personalized Lung Recruitment Pressure Group

Lung Recruitment Maneuver PROCEDURE

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.

Fixed Lung Recruitment Pressure Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Ju Gao: lead

Central Study Contacts

Ju Gao

CONTACT

18051063988; doctor2227@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 6, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share