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临床试验/NCT06117748
NCT06117748招募中不适用

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

Ain Shams University2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
2
主要终点
Oxygenation index

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.
  • Patients with advanced malignancy.
  • Pregnant females.

结局指标

主要结局

Oxygenation index

时间窗: Till the end of surgery

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maamoun Maamoun Soliman

Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Ain Shams University

研究点 (2)

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