NCT05222893

Optimization of PEEP During Laparoscopic Surgery

Optimization of Positive End-expiratory Pressure During Laparoscopic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Karaganda Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Lung-protective ventilation (LPV) during general anesthesia can trigger the development of early postoperative pulmonary complication (PPC) and ventilator associated lung injury. One of the proven components of the LPV is low tidal volume (TV). Data on the positive end-expiratory pressure (PEEP) parameters adjustment in laparoscopic surgery, as well as the effects on the respiratory biomechanics, lung tissue and respiratory muscles damage are limited and not clear. The objective of the study is to evaluate the ability of the esophageal pressure (Pes) based controlled personalized PEEP adjustment, to improve the biomechanics of the respiratory system and oxygenation due to laparoscopic cholecystectomy.

Detailed description

During laparoscopic surgery pressure on alveoli increases, due to in the conditions of pneumoperitoneum, muscle relaxation, the patient's position on the operating table, excess body weight and other factors. As the consequence, the alveoli collapse due to negative transpulmonary pressure. The personalized PEEP adjustment for each particular patient during laparoscopic surgery can help to avoid the adverse effects on biomechanical parameters of the respiratory system, the early PPC incidence and improve overall patients' recovery. The objective of the study is to evaluate the ability of the esophageal pressure (Pes) based controlled personalized PEEP adjustment, to improve the biomechanics of the respiratory system and oxygenation due to laparoscopic cholecystectomy. Investigators will measure if PEEP adjustment according to the pressure indicators in the lower third of the esophagus Pes (intervention group) versus PEEP constantly set at 5 cmH2O (control group) gives better outcomes and prevent the early PPC incidence in hospitals. After the induction, intubation and insertion of the esophageal balloon catheter, TV for patients both groups is set to 6 ml / kg BMI: for men (50+0.91\* (height-152.4), for women (45+0.91\* (height-152.4); minute ventilation (MV) to ensure the level of PetCO2 - 30-35 mmHg, respiratory rate (RR) 15-25/min (maximum up to 35/min). Gas exchange parameters including partial pressures of oxygen (PaO2) and carbon dioxide (PaCO2) in arterial blood will be measured before the induction (T0), after 1 hour after surgery (T5) and after 24 hours after surgery (T6), then will calculate PAO2/FiO2 respectively. FiO2, oxygen saturation (SpO2), hemodynamic parameters including blood pressure (BP), heart rate (HR) will be recorded in all point of the study. Following respiratory mechanics will be measured: plateau pressure (Pplat), PEEP, driving pressure (DP), Pes during inspiration and expiration, volumetric capnometry (VCO2), end-tidal carbon dioxide tension (PetCO2). Respiratory system compliance (Cstat, Cl, Ccw), end-expiratory lung volume (EELV) will calculated after intubation (T1), after PEEP set according to the patient's group allocation PEEP Pes and PEEP 5 (T2), after initiating pneumoperitoneum (T3) and placing the patient in the reverse Trendelenburg position (T4). This is a randomized controlled study in the operating room of the University hospitals.

Conditions

• Post-Op Complication
• Ventilator-Induced Lung Injury

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Respiratory monitoring	Measurement of the plateau pressure, positive end-expiratory pressure, driving pressure, end-expiratory lung volume, compliance of respiratory system on volume-controlled ventilation
DIAGNOSTIC_TEST	Capnography	Measurement of end-tidal carbon dioxide tension, volume of CO2 eliminated per minute
DIAGNOSTIC_TEST	Arterial blood gas	Measurement of the oxygen partial pressure and the carbon dioxide partial pressure
DEVICE	Esophageal pressure	Measurement the pressure in the lower third of esophagus during inspiration and expiration

Timeline

• Start date: 2021-04-14
• Primary completion: 2023-12-29
• Completion: 2024-03-26
• First posted: 2022-02-03
• Last updated: 2024-04-12

Locations

1 site across 1 country: Kazakhstan

Regulatory

• FDA-regulated device study