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临床试验/CTRI/2025/02/080319
CTRI/2025/02/080319尚未招募3 期

Effects of volume-controlled ventilation versus pressure controlled ventilation on perioperative respiratory functions and postoperative ventilator requirement, in patients posted for intracardiac repair for congenital heart diseases with severe PAH.

Sharayu Paunikar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月25日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Effects of Volume-Controlled Ventilation Versus Pressure Controlled Ventilation on Respiratory Functions and Duration of Ventilatory Requirement, Postoperatively, in Patients with Severe PAH, Posted for Intrathoracic Repairs

研究概览

简要总结

Raised blood pressure levels in the pulmonary arteries cause pulmonary arterial hypertension (PAH), a rare but potentially fatal illness that severely impairs lung function and causes right heart failure. Respiratory problems are a significant concern throughout the perioperative phase for individuals with severe PAH who require intrathoracic surgical procedures. Selecting a mechanical ventilation approach for these patients is a crucial part of their perioperative care. Two popular types of mechanical ventilation, with pros and cons, are Volume-Controlled Ventilation (VCV) and Pressure-Controlled Ventilation (PCV). By methodically comparing the effects of pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) on respiratory functions and the length of ventilatory support in patients with severe PAH who are posted for intrathoracic repairs, this study seeks to address this critical knowledge gap. Compromised respiratory and cardiovascular systems are standard in patients with severe PAH. The decision between VCV and PCV must consider factors such as total respiratory efficiency, hemodynamic stability, and lung protection—all of which are critical to the health of these high-risk patients. This study seeks to provide critical evidence-based insights about the most appropriate ventilation method for patients with severe PAH having intrathoracic repairs, as there is currently no consensus in the literature and clinical practice in this area.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with severe PAH Patients slated to undergo intrathoracic surgeries.
  • Patients who provide valid informed consent to participate in the study.

排除标准

  • Patients with mild to moderate PAH, Patients with pre-existing lung disorders, Patients with severe diseases of the cardiovascular, respiratory, and neurological systems.
  • Patients with low left ventricular ejection fraction, Patients with impaired renal and hepatic parameters, Patients posted for emergency procedures Patients who will require one-lung ventilation for the procedures Patients not giving a valid consent to participate in the study.

结局指标

主要结局

Effects of Volume-Controlled Ventilation Versus Pressure Controlled Ventilation on Respiratory Functions and Duration of Ventilatory Requirement, Postoperatively, in Patients with Severe PAH, Posted for Intrathoracic Repairs

时间窗: 72 hours

次要结局

未报告次要终点

研究者

发起方
Sharayu Paunikar
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Sharayu Paunikar

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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