跳至主要内容
临床试验/CTRI/2025/06/088653
CTRI/2025/06/088653尚未招募不适用

Comparison of high flow nasal cannula versus standard oxygen therapy assisted sedation during endoscopic retrograde cholangiopancreatography

Army hospital Research and Referral1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年6月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Incidence of hypoxemia spo2 less than 95% for 10 seconds and severe hypoxemia spo2 less than 90% for 10seconds during procedural time

研究概览

简要总结

ERCP is a common diagnostic and therapeutic procedure often require sedation. The incidence of hypoxemia noted during ERCP under sedation presumably because lengthy procedure, endoscopist share common airway and is performed in semiprone or pronr postion. The choice of oxygen method during sedation play a crucial role in safety and outcomes as well as patient comfort.

Use of HFNC is widened to critical care and day care procedures in non operating room anesthesia settings under sedation.

Very few similar studies conducted in Indian population .

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 70.00 Year(s)(—)
性别
All

入选标准

  • ASA Physical status class I-III , schedule for elective ERCP under sedation.

排除标准

  • Age less than 18yrs or more than 70yrs with coexisting respiratory, cardiac illness, dementia, cognitive disorder, pregnancy, allergic to Propofol and Fentanyl, anticipated difficult intubation , tracheostomized, emergency ERCP.

结局指标

主要结局

Incidence of hypoxemia spo2 less than 95% for 10 seconds and severe hypoxemia spo2 less than 90% for 10seconds during procedural time

时间窗: At baseline and T1,5,10,15,20,30,45,60,75(minutes) and PACU

次要结局

  • Total Propofol consumption(At end of procedure in PACU)
  • Need of assisted ventilation(During procedure in between when required & requirement episodes will be recorded)
  • Airway manipulation(During procedure & episodes will be recorded)
  • Endoscopist & Patient satisfaction(At end of Procedure)
  • Total procedural duration(At end of procedure)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr D R Famara

Army Hospital Research and Referral, Delhi

研究点 (1)

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