Optimization of PEEP During Laparoscopic Surgery

Optimization of Positive End-expiratory Pressure During Laparoscopic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Ventilator-Induced Lung Injury; Post-Op Complication
• Intervention / Treatment: Diagnostic test: Respiratory monitoring; Diagnostic test: Capnography; Diagnostic test: Arterial blood gas; Device: Esophageal pressure

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kazakhstan
  • Select
    • Astana, Select, Kazakhstan, 010000
      • National Research Oncology and Transplantology Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PEEP Pes; PEEP adjustment according to the pressure indicators in the lower third of the esophagus Pes (intervention group)	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
Active Comparator: PEEP 5; PEEP constantly set at 5 cmH2O (control group)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio	Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement and compare between groups	5 minutes before intubation,1 hour after surgery, 24 hour after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamics of the end-expiratory lung volume	Calculation the end-expiratory lung volume (ml) and compare with expected and between groups	5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Dynamics of the respiratory biomechanics	Calculation the compliance of respiratory system (ml/mbar) and compare between groups at all time points	5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Dynamics of the volume of CO2 eliminated per minute	Measurement of volume of CO2 eliminated per minute (VCO2 in ml/min), than compare the trends as a marker of lung ventilation	5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Dynamics of the partial pressure of CO2 in exhaled gas	Measurement of partial pressure of CO2 in exhaled gas (PetCO2 in mmHg) than compare the trends as a marker of lung ventilation	5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Dynamics of the hemodynamic parameters	Measurement of the arterial blood pressure (mmHg) and compare between groups at all time points	5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position

Collaborators and Investigators

• Sponsor: Karaganda Medical University
• Collaborators: I.M. Sechenov First Moscow State Medical University; National Research Oncology and Transplantology Center, Kazakhstan

Publications and helpful links

General Publications

• Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
• Barbosa FT, Castro AA, de Sousa-Rodrigues CF. Positive end-expiratory pressure (PEEP) during anaesthesia for prevention of mortality and postoperative pulmonary complications. Cochrane Database Syst Rev. 2014 Jun 12;(6):CD007922. doi: 10.1002/14651858.CD007922.pub3.
• Bender SP, Paganelli WC, Gerety LP, Tharp WG, Shanks AM, Housey M, Blank RS, Colquhoun DA, Fernandez-Bustamante A, Jameson LC, Kheterpal S. Intraoperative Lung-Protective Ventilation Trends and Practice Patterns: A Report from the Multicenter Perioperative Outcomes Group. Anesth Analg. 2015 Nov;121(5):1231-9. doi: 10.1213/ANE.0000000000000940.
• Kacmarek RM, Villar J. Lung-protective Ventilation in the Operating Room: Individualized Positive End-expiratory Pressure Is Needed! Anesthesiology. 2018 Dec;129(6):1057-1059. doi: 10.1097/ALN.0000000000002476. No abstract available.
• Iaroshetskii AI, Protsenko DN, Rezepov NA, Gel'fand BR. [Positive end-expiratory pressure adjustment in parenchimal respiratory failure: static pressure-volume loop or transpulmonary pressure?]. Anesteziol Reanimatol. 2014 Jul-Aug;59(4):53-9. Russian.
• Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): March 26, 2024

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopic surgery; esophageal pressure; positive end-expiratory pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Postoperative Complications; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: PEEP-TPP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes