Esophageal Pressure-guided Personalized Recruitment Pressure During Pneumoperitoneum in Trendelenburg Position Laparoscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJu Gao
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Esophageal Pressure
Procedure/SurgeryA 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.
Lung Recruitment Maneuver
Procedure/SurgeryA 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Personalized Lung Recruitment Pressure GroupExperimental treatment 1 intervention
Group B: Fixed Lung Recruitment Pressure GroupOther 1 intervention
Trial outcomes
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.
Time frame
From the establishment of pneumoperitoneum until the end of surgery.Locations
Sponsors and contacts
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Ju Gao
Lead sponsor
Northern Jiangsu People's Hospital
Sponsor institution
Source ClinicalTrials.gov
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