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临床试验/CTRI/2025/08/092245
CTRI/2025/08/092245尚未招募2 期

Comparison of the effect of ultrasound guided and conventional lung recruitment manoeuvres in trendelenburg robotic surgery

Vardhman Mahavir Medical College and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To assess the changes in lung ultrasound scores after ultrasound guided lung recruitment manoeuvres and conventional lung recruitment manoeuvres in patients undergoing trendelenburg robotic surgery

研究概览

简要总结

This study is a prospective, randomised, interventional, and comparative study to compare the effect of ultrasound guided and conventional lung recruitment manoeuvres in patients undergoingTrendelenburg robotic surgery, with the hypothesis that ultrasound guided recruitment manoeuvres have better efficacy as compared to the conventional lung recruitment manoeuvres. A baseline lung ultrasound score will be calculated before the induction of anaesthesia. In both the groups lung ultrasound examination will be done at two predefined time points ,five minutes after the induction of anesthesia and five minutes before extubation. After lung  ultrasound examination, recruitment manoeuvres will be performed. In one group recruitment manoeuvres will be performed under direct real time  guidance of ultrasound where in manual inflation will be applied till no collapse area is visible on the ultrasound. The maximum airway pressure will be adjusted 40 cm H2O. In the sustained inflation group recruitment manoeuvre will be performed by manual inflation with pressure of 30 cm for 10 seconds. Lung ultrasound score will be calculated 30 minutes after extubation when the patient is in recovery room. Patient will be observed in postop ward for one hour.

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18-65 years belonging to American society of anaesthesiology Physical status I and II undergoing trendelenburg robotic surgery under general anaesthesia.

排除标准

  • body mass index greater than 35 KG per metre square
  • Any obstructive or restrictive pulmonary disease
  • Previous history of thoracic surgery, pneumothorax, bullae preexisting lung or cardiac disorder.

结局指标

主要结局

To assess the changes in lung ultrasound scores after ultrasound guided lung recruitment manoeuvres and conventional lung recruitment manoeuvres in patients undergoing trendelenburg robotic surgery

时间窗: To assess the changes in lung, ultrasound scores after ultrasound guided lung recruitment manoeuvres and conventional lung recruitment manoeuvres in patients undergoing trendelenburg robotic surgery 5 minutes after induction of general anaesthesia and 5 minutes before extubation

次要结局

  • 1. To assess the lung ultrasound score at the time of discharge of the patient from recovery room.(2. To assess intra operative changes in oxygenation using intra operative oxygen saturation and arterial blood gas analysis.)

研究者

发起方
Vardhman Mahavir Medical College and Safdarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shrishti Choudhary

Vardhman Mahavir Medical college and Safdarjung hospital

研究点 (1)

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