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临床试验/CTRI/2026/01/102257
CTRI/2026/01/102257尚未招募不适用

COMPARISON OF EFFECTS OF PRESSURE-CONTROLLED VENTILATION AND MANUAL VENTILATION ON PEAK AIRWAY PRESSURE AND GASTRIC INSUFFLATION DURING INDUCTION OF GENERAL ANAESTHESIA–A RANDOMISED CONTROL STUDY

Shri BM Patil Medical College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2026年2月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
153
试验地点
1
主要终点
Compare Peak Airway Pressure between Pressure Control Ventilation and Manual Ventilation during induction of general Anaesthesia

研究概览

简要总结

This study is a prospective, randomized controlled trial designed to compare the effects of pressure-controlled ventilation (PCV) and manual ventilation (MV) on peak airway pressure and gastric insufflation during induction of general anaesthesia. Facemask ventilation is a critical component of airway management during induction; however, excessive airway pressure may lead to gastric insufflation, increasing the risk of regurgitation and aspiration.

A total of 154 adult patients scheduled for elective surgeries under general anaesthesia will be randomly allocated into two groups: Group PCV (pressure-controlled ventilation) and Group MV (manual ventilation). After standard induction of anaesthesia and neuromuscular blockade, patients will receive mask ventilation for 180 seconds according to their allocated group. Peak airway pressure, end-tidal carbon dioxide, oxygen saturation, heart rate, and mean arterial pressure will be recorded at 30-second intervals. Gastric insufflation will be assessed using epigastric auscultation and ultrasonography.

The primary outcome is comparison of peak airway pressure between the two ventilation techniques. The secondary outcome is the incidence of gastric insufflation during mask ventilation. This study aims to determine whether pressure-controlled ventilation provides safer airway dynamics and reduces gastric insufflation compared to manual ventilation during induction of general anaesthesia.

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

  • 1.Patients aged 18 to 60 years receiving elective procedures under general anaesthesia.
  • 2.Patients were classed as American Society of Anaesthesiologists (ASA) 1 and 2 following a complete pre-anaesthetic examination.

排除标准

  • 1.Patient refusal.
  • 2.Pregnant woman.
  • 3.Patients having a BMI of 30 kg/m2 or higher.
  • 4.Patients with anticipated difficult airway 5.Patients with oropharyngeal/facial pathologies 6.Patients who actively smoke.

结局指标

主要结局

Compare Peak Airway Pressure between Pressure Control Ventilation and Manual Ventilation during induction of general Anaesthesia

时间窗: Compare Peak Airway Pressure between Pressure Control Ventilation and Manual Ventilation during induction of general Anaesthesia

次要结局

  • •Compare End Tidal CO2 levels between Pressure Control Ventilation & Manual Ventilation during anesthesia induction.(•To compare gastric insufflation rates during anaesthesia induction using Pressure Control Ventilation & Manual Ventilation methods)

研究者

发起方
Shri BM Patil Medical College Hospital and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Darshan Gowda G S

Shri B.M. Patil Medical College Hospital and Research Centre

研究点 (1)

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