Post-Op Complication, Ventilator-Induced Lung Injury
Conditions
Keywords
positive end-expiratory pressure, esophageal pressure, laparoscopic surgery
Brief 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.
Interventions
DIAGNOSTIC_TESTRespiratory 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_TESTCapnography
Measurement of end-tidal carbon dioxide tension, volume of CO2 eliminated per minute
DIAGNOSTIC_TESTArterial blood gas
Measurement of the oxygen partial pressure and the carbon dioxide partial pressure
DEVICEEsophageal pressure
Measurement the pressure in the lower third of esophagus during inspiration and expiration
Sponsors
I.M. Sechenov First Moscow State Medical University
National Research Oncology and Transplantology Center, Kazakhstan
Karaganda Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing laparoscopic surgery with mechanical lung ventilation American Society of Anesthesiologists Classification (ASA) I-III
Exclusion criteria
* pregnancy * age less than 18 or more than 70 years * patients ASA \> III * life-threatening heart rhythm abnormalities and/or systolic blood pressure \< 80 mmHg despite norepinephrine at a dose \> 2 μg/kg/min * primary lung diseases (e.g. interstitial lung diseases, lung emphysema) or tumor metastases in the lungs * chronic decompensated diseases with extrapulmonary organ dysfunction (tumor progression, liver cirrhosis, congestive heart failure) * Glasgow coma score \< 14 * upper airways obstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio | 5 minutes before intubation,1 hour after surgery, 24 hour after surgery | Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement and compare between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamics of the end-expiratory lung volume | 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position | Calculation the end-expiratory lung volume (ml) and compare with expected and between groups |
| Dynamics of the respiratory biomechanics | 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position | Calculation the compliance of respiratory system (ml/mbar) and compare between groups at all time points |
| Dynamics of the volume of CO2 eliminated per minute | 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position | Measurement of volume of CO2 eliminated per minute (VCO2 in ml/min), than compare the trends as a marker of lung ventilation |
| Dynamics of the partial pressure of CO2 in exhaled gas | 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position | Measurement of partial pressure of CO2 in exhaled gas (PetCO2 in mmHg) than compare the trends as a marker of lung ventilation |
| Dynamics of the hemodynamic parameters | 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position | Measurement of the arterial blood pressure (mmHg) and compare between groups at all time points |
Countries
Kazakhstan
Outcome results
None listed