临床试验/CTRI/2024/01/061658

CTRI/2024/01/061658招募中不适用

Comparison of pre-procedure vs real-time ultrasound guided percutaneous dilatational tracheostomy assessed by tracheal view using flexible endoscope

Command Hospital EC1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2024年2月1日最近更新: 2024年3月4日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 30
试验地点: 1
主要终点: Accuracy of first puncture. Graded 1 is central puncture, Grade 2 is not grade 1 but still acceptable and visible by bronchoscope and grade 3 where puncture needle is not visualized.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Adult endotracheally intubated patients in ICU who required tracheostomy will be recruited, after informed consent from next of kin. Patients will be randomized to pre-procedure vs real-time ultrasound guided percutaneous tracheostomy group. Accuracy of tracheal puncture will be assessed by tracheal view using flexible endoscope and compared between the two groups. Time taken to perform the percutaneous tracheostomy will also be compared between the groups.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•All adult patient in our ICU planned for percutaneous tracheostomy.

排除标准

•Bleeding disorder infection at the proposed puncture site Unwillingness.

结局指标

主要结局

Accuracy of first puncture. Graded 1 is central puncture, Grade 2 is not grade 1 but still acceptable and visible by bronchoscope and grade 3 where puncture needle is not visualized.

时间窗: On the first attempted puncture by puncture needle.

次要结局

Time taken for the procedure from positioning to successful tracheal puncture(Will be recorded by an observer during the procedure)

研究者

发起方

Command Hospital EC

申办方类型

Government medical college

责任方

Principal Investigator

主要研究者

Abraham Lalchhana Chawnchhim

Army Medical Corps

研究点 (1)

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