Skip to main content
Clinical Trials/NCT06117748
NCT06117748
Recruiting
Not Applicable

Comparative Study Between the Effect of Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic Assisted Surgery

Ain Shams University1 site in 1 country64 target enrollmentNovember 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Volume-Controlled Ventilation
Sponsor
Ain Shams University
Enrollment
64
Locations
1
Primary Endpoint
Oxygenation index
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The aim of this study is to compare the efficacy of the pressure controlled ventilation volume-guaranteed (PCV-VG) versus volume-controlled ventilation (VCV) modes as regards lung compliance and oxygenation index in obese patients undergoing laparoscopic assisted surgery especially in Trendelenburg position.

Detailed Description

Obesity, defined as a Body Mass Index (BMI) \>30 kg.m-2", is characterized by increased airway resistance, labored breathing and decreased respiratory system compliance. An increased rate of obese patients undergoing laparoscopic assisted surgery (LAS) is a health care concern due to anesthesia and ventilation difficulties in the obese population. Therefore, understanding the physiology and pathophysiology of lung function is an important issue during long-lasting LAS. Carbon dioxide pneumoperitoneum with steep Trendelenburg positioning leads to a cranial displacement of the diaphragm and an increased volume of atelectasis, with a consequent decrease of total lung volume, lung compliance, and functional residual capacity. Thus, alleviation of increased airway pressure, improvement in oxygenation and CO2 elimination are the main goals during anesthetic management in laparoscopic assisted surgery. In pressure controlled ventilation volume-guaranteed (PCV-VG) mode, the ventilator regulates the Peak Inspiratory Pressure (PIP) to achieve the optimal TV. To achieve the target volume, ventilator parameters are regularly changed without adjusting airway pressures. Hence, PCV-VG has the advantages of both Volume-Controlled Ventilation (VCV) and pressure controlled ventilation (PCV) to preserve the target minute ventilation while maintaining a low incidence of barotraumas. PCV-VG is a type-controlled ventilation mode with a dual character as it has the criteria of both PCV and VCV. This recent ventilation mode which is one of the pressure regulated volume controlled (PRVC) that include Auto Flow ventilation, offers the ability to reduce the inspiratory pressure and as a result the incidence of barotrauma

Registry
clinicaltrials.gov
Start Date
November 5, 2023
End Date
July 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Maamoun Maamoun Soliman

Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Age: 16 - 60 years old.
  • Sex: both males and females.
  • Undergoing elective Laparoscopic Surgery.
  • Obese patient with Body Mass Index between ≥30 Kg/m
  • American society of Anesthesiologist (ASA) class I/ II.

Exclusion Criteria

  • Patient refusal.
  • American society of Anesthesiology (ASA) III or IV.
  • Intraoperative hemodynamic instability.
  • Patients with pulmonary hypertension.
  • Obese patients on home O2 therapy
  • Pneumoperitoneum with CO2 with intra-abdominal pressure exceeding 15mmHg.
  • Anti-Trendelenburg position.
  • Asthmatic Patients.
  • Patients with advanced liver disease.
  • Patients with advanced renal disease.

Outcomes

Primary Outcomes

Oxygenation index

Time Frame: Till the end of surgery

Oxygenation index =mean airway pressure × fraction of inspired oxygen (FiO2) × 100÷ Partial pressure of oxygen (PaO2)

Secondary Outcomes

  • Arterial PCo2(Till the end of surgery)
  • Heart rate(Till the end of surgery)
  • Lung compliance(Till the end of surgery)
  • Oxygen saturation SpO2(Till the end of surgery)
  • Mean arterial blood pressure(Till the end of surgery)

Study Sites (1)

Loading locations...

Similar Trials