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临床试验/NCT04082208
NCT04082208Unknown不适用

Use of High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) Under Sedation. Comparative, Randomized Study of Two Health Products Approved by the Community

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
172
试验地点
2
主要终点
Desaturation during ERCP

研究概览

简要总结

The expected results with this study are that high flow devices (LAF) provide adequate respiratory support during the performance of ERCP under deep sedation, reducing episodes of desaturation, hypoventilation and airway obstruction compared to low flow devices ( nasal glasses).

详细描述

Deep sedation performed during the ERCP technique associates an increased risk of decrease in Sat02%, hypercapnia and airway obstruction with consequences ranging from interruption or suspension of the technique to complications that may put the patient's life at risk .

High flow devices (HF) due to the pressurization capacity of the airway and the reduction of anatomical dead space will favor a better gas exchange compared to low flow devices (LF), which will manifest clinically with a reduction in episodes of decrease of Sat02% and a decrease in carbon dioxide levels.

The main objective of the study is to demonstrate that the use of high flow devices (HF) decreases the episodes of desaturation (defined as Sat02 ≤ 90% measured through pulse oximetry) that occur during the performance of ERCP under deep sedation compared to Low flow devices (LF) with equal Inspiratory oxygen fraction (Fi02) in both cases.

The expected results with this study are that high flow devices (LAF) provide adequate respiratory support during the performance of ERCP under deep sedation, reducing episodes of desaturation, hypoventilation and airway obstruction compared to low flow devices ( nasal glasses).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients Age over ≥18 years. Willing to participate

排除标准

  • 未提供

结局指标

主要结局

Desaturation during ERCP

时间窗: 2 years

Demonstrate that the use of high flow devices (HF) decreases episodes of desaturation (defined as Sat02 ≤ 90% measured by pulse oximetry) that occur during the performance of ERCP under deep sedation compared to low flow devices ( LF).

次要结局

  • CO2 during ERCP(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JULIA MARTÍNEZ OCÓN

Anesthesiologist

Hospital Clinic of Barcelona

研究点 (2)

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