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临床试验/NCT07611903
NCT07611903招募中不适用

HFNC Versus Microstream Advance Nasal Cannula for Oxygenation During ERCP

Kocaeli University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2026年7月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
74
试验地点
1

研究概览

简要总结

Endoscopic retrograde cholangiopancreatography (ERCP) procedures are commonly performed under deep sedation and are associated with a risk of hypoxemia, particularly in prone or semi-prone positions. High-flow nasal cannula (HFNC) therapy may improve oxygenation by delivering heated and humidified oxygen at high flow rates, while the Microstream Advance nasal cannula provides simultaneous nasal oxygen delivery and oral oxygen insufflation.

This prospective randomized study aims to compare the effectiveness of HFNC and Microstream Advance nasal cannula in maintaining oxygenation during ERCP procedures. Patients undergoing ERCP will be randomized into two groups receiving either HFNC or Microstream Advance nasal cannula oxygen support during sedation.

The primary outcomes are the incidence of desaturation and oxygen reserve index (ORi) measurements during the procedure. Secondary outcomes include time to achieve target ORi levels, respiratory complications, and procedure-related adverse events.

研究设计

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

盲法说明

Due to the nature of the oxygen delivery devices, masking of participants and care providers was not feasible.

入排标准

年龄范围
18 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 to 84 years
  • ASA physical status I-III
  • Patients scheduled to undergo ERCP
  • Patients who provide written informed consent

排除标准

  • Recent history of upper respiratory tract infection
  • History of lung cancer
  • Chronic obstructive pulmonary disease
  • Body mass index greater than 35 kg/m²
  • Refusal to participate in the study

研究组 & 干预措施

HFNC Group

Experimental

Participants receive oxygen support with high-flow nasal cannula (HFNC) during ERCP under sedation.

干预措施: High-flow nasal canula (Device)

Microstream Advance Nasal Cannula Group

Active Comparator

Participants receive oxygen support with Microstream Advance nasal cannula during ERCP under sedation.

干预措施: Microstream advance nasal cannula (Device)

研究者

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

Volkan Alparslan

Assistant Professor

Kocaeli University

研究点 (1)

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