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Optimization of PEEP During Laparoscopic Surgery

NCT05222893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    collaborator OTHER

  • National Research Oncology and Transplantology Center, Kazakhstan

    collaborator OTHER

  • Karaganda Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2023-12-29
Completion
2024-03-26
FDA Device
Yes

Countries

  • Kazakhstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05222893 on ClinicalTrials.gov