Esophageal Pressure-guided Personalized Recruitment Pressure During Pneumoperitoneum in Trendelenburg Position Laparoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Esophageal Pressure, Lung Recruitment Maneuver.
- Who it may be relevant to
- Registry conditions: Esophageal Pressure, Recruitment Maneuver. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Esophageal Pressure-guided Personalized Recruitment Pressure During Pneumoperitoneum in Trendelenburg Position Laparoscopy: A Prospective Randomized Controlled Trial
Overview
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.
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 lun - 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.
Primary outcome measures
- Lung Compliance [Time frame: From the establishment of pneumoperitoneum until the end of surgery.]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07392918 · 2026KY021