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临床试验/CTRI/2025/07/091987
CTRI/2025/07/091987
招募中
不适用

Comparing two modes of ventilation in laproscopic surgeries in Trendelenburg position, Pressure Controlled Ventilation - Volume Guaranteed mode vs Volume Controlled Ventilation mode, A randomised controlled trial.

Adithya Sony Raj1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年8月11日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Adithya Sony Raj
入组人数
70
试验地点
1
主要终点
Peak airway pressure (P peak) after initiation of pneumoperitoneum measured at defined intervals.

概览

简要总结

Laparoscopic surgery often requires the Trendelenburg position, which, along with pneumoperitoneum, increases intra-abdominal pressure and CO2 absorption. This can lead to hypercapnia, acidosis, and impaired ventilation. The upward shift of the diaphragm further reduces pulmonary compliance, functional residual capacity, and worsens ventilation/perfusion mismatch. These challenges call for tailored ventilation strategies to ensure optimal oxygenation and carbon dioxide elimination while minimizing ventilator- induced lung injury. Volume Controlled Ventilation (VCV), Pressure Controlled Ventilation (PCV) and Pressure Controlled Ventilation-Volume Guaranteed (PCV-VG) are three commonly used modes in such settings. VCV delivers a set tidal volume regardless of airway pressures, potentially leading to high peak pressures in patients with reduced compliance. PCV delivers breaths at a preset pressure with decelerating flow decreasing the risk of barotrauma whilst compromising on minute ventilation in non-compliant lungs. On the other hand, PCV-VG is a hybrid mode designed to combine the benefits of both pressure and volume-controlled ventilation, aiming to deliver consistent tidal volume with lower airway pressures by adjusting inspiratory pressure as compliance changes.This study aims to compare VCV and PCV-VG ventilation modes in laparoscopic surgeries under Trendelenburg position, assessing their impact on respiratory mechanics, gas exchange, and pulmonary compliance. The findings could help refine anaesthesia practices, ensuring better perioperative outcomes and minimizing ventilatory complications.Primary objective: To compare peak airway pressures (P peak) in VCV and PCV-VG mode of ventilation in patients undergoing laproscopy surgery in Trendelenburg position. The parameters with respect to respiratory mechanics (mean airway pressure, dynamic compliance) and hemodynamic changes will also be taken into account.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective laparoscopic surgeries in Trendelenburg position.
  • ASA physical status I & II
  • BMI less than or equal to 30 Kg/m2.

排除标准

  • Refusal for the study
  • Any contraindication for general anaesthesia
  • Severe obstructive or restrictive pulmonary disease
  • Suspected difficult intubation
  • Presence of any intracranial pathology.

结局指标

主要结局

Peak airway pressure (P peak) after initiation of pneumoperitoneum measured at defined intervals.

时间窗: T1- 5 minutes after induction in the supine position and before initiation of the | pneumoperitoneum. | T2- 10 minutes after creation of pneumoperitoneum and achieving a stable peak | pneumoperitoneum level of 12 – 14 mmHg for 5 minutes. | T3- 15 minutes after positioning the patient in Trendelenburg position. | T4- 10 minutes after pneumoperitoneum withdrawal, in the supine position.

次要结局

  • Respiratory mechanics like P mean & dynamic compliance in both the groups(intraoperative)
  • Hemodynamic changes (SBP, DBP, MAP & HR) at defined intervals.(intraoperative)
  • Final ventilator settings - Expiratory tidal volume & respiratory rate required to achieve a stable ETCO2 of 35 - 40 mm of Hg.(intraoperative)
  • Incidence of sore throat in both groups & it will be assessed by a four-point categorical pain scale.(intraoperative)
  • ET tube insertion - number of attempts & success rate of insertion in both the groups(intraoperative)
  • Oropharyngeal leak pressure (OLP)measured by closing the expiratory valve of closed circuit at fixed gas flow & noting the equilibrium airway pressure.(intraoperative)

研究者

发起方
Adithya Sony Raj
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Adithya Sony Raj

Ballari medical college and research centre, Ballari

研究点 (1)

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