Optimization of PEEP During Laparoscopic Surgery

NCT05222893 | Completed FDA Device

• 1 other identifier: PEEP-TPP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Op Complication; Ventilator-Induced Lung Injury

Keywords

positive end-expiratory pressure; esophageal pressure; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

PEEP Pes

ACTIVE COMPARATOR

PEEP adjustment according to the pressure indicators in the lower third of the esophagus Pes (intervention group)

Diagnostic Test: Respiratory monitoring; Diagnostic Test: Capnography; Diagnostic Test: Arterial blood gas; Device: Esophageal pressure

PEEP 5

ACTIVE COMPARATOR

PEEP constantly set at 5 cmH2O (control group)

Diagnostic Test: Respiratory monitoring; Diagnostic Test: Capnography; Diagnostic Test: Arterial blood gas; Device: Esophageal pressure

Interventions

Respiratory monitoring DIAGNOSTIC_TEST

Measurement of the plateau pressure, positive end-expiratory pressure, driving pressure, end-expiratory lung volume, compliance of respiratory system on volume-controlled ventilation

PEEP 5; PEEP Pes

Capnography DIAGNOSTIC_TEST

Measurement of end-tidal carbon dioxide tension, volume of CO2 eliminated per minute

PEEP 5; PEEP Pes

Arterial blood gas DIAGNOSTIC_TEST

Measurement of the oxygen partial pressure and the carbon dioxide partial pressure

PEEP 5; PEEP Pes

Esophageal pressure DEVICE

Measurement the pressure in the lower third of esophagus during inspiration and expiration

PEEP 5; PEEP Pes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing laparoscopic surgery with mechanical lung ventilation American Society of Anesthesiologists Classification (ASA) I-III

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

National Research Oncology and Transplantology Centre

Astana, Select, 010000, Kazakhstan

Location

Related Publications (6)

• 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;2014(6):CD007922. doi: 10.1002/14651858.CD007922.pub3.

  PMID: 24919591 BACKGROUND

• 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.

  PMID: 26332856 BACKGROUND

• 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.

  PMID: 30277931 BACKGROUND

• 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.

  PMID: 19001507 BACKGROUND

• 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.

  PMID: 25549487 BACKGROUND

• 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.

  PMID: 30260897 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Ventilator-Induced Lung Injury

Interventions

Capnography; Blood Gas Analysis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: February 3, 2022
• Study Start: April 14, 2021
• Primary Completion: December 29, 2023
• Study Completion: March 26, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

KA (1)