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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Pressure; Recruitment Maneuver
• Intervention / Treatment: Procedure: Esophageal Pressure; Procedure: Lung Recruitment Maneuver

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ju Gao; Phone Number: 18051063988; Email: doctor2227@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:1.Age 18-65 years.2.No restriction on sex.3.ASA physical status classification I-III.4.Scheduled for elective tracheal intubation under general anesthesia in the ead-down (Trendelenburg) position for laparoscopic surgery.5.No recent history of pulmonary infection or respiratory disease, and no prior respiratory-system surgery.

Exclusion Criteria:1.Chronic obstructive pulmonary disease (COPD) or cor pulmonale.2.Poorly controlled chronic diseases such as diabetes mellitus or hypertension.3.Cardiac dysfunction.4.Recent use of non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.5.Esophageal pathology (contraindication to esophageal balloon catheter placement).6.History of esophageal surgery.7.Contraindications to lung recruitment maneuvers: intracranial hypertension, hypovolemic shock, right-heart failure.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized Lung Recruitment Pressure Group; 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; 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.; Other Names: Transpulmonary Pressure; Pleural Pressure
Other: Fixed Lung Recruitment Pressure Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Ju Gao

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 31, 2026
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Esophageal Pressure; Laparoscope; Trendelenburg Position; Recruitment Maneuver
• Other Study ID Numbers: 2026KY021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No