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临床试验/NCT06218017
NCT06218017招募中不适用

Development of Algorithm to Precise Monitoring Respiratory Sound During Deep Sedation Using the High Flow Nasal Oxygen System

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Tracheal sound with and without high-flow nasal oxygen will be measured to develop an algorithm to mitigate the high flow nasal oxygen-generated tracheal noise

研究概览

简要总结

This study aims to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.

详细描述

During deep sedation without intubation, anesthesia respiratory care and monitoring are of utmost importance. Anesthesia can lead to adverse respiratory effects, increasing the risk of airway obstruction and respiratory depression. High-flow nasal oxygen (HFNO) systems are often used to mitigate these risks. Monitoring tracheal breathing sounds directly using amplification provides better detection accuracy. However, traditional auscultation instruments have limitations, including noise interference and lack of visual functionality. The Airmod Smart Respiratory Monitoring System, with FDA approval in the United States and Taiwan, addresses these issues. It offers respiratory sound recording, noise filtering, event logging, and respiratory rate analysis. Currently, no digital stethoscope on the market can filter out HFNO noise. Therefore, the current study is to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •Adult patients undergoing elective gastroinestinal endoscoy requiring deep sedation

排除标准

  • •Histories of sleep apnea, chronic obstructive pulmonary disease, or oropharyngeal tumor
  • •Patient who has a hisotry of previous intraoral surgery, tracheal surgery or pulmonary resection surgery

研究组 & 干预措施

HFNO first

Experimental

This study follows a crossover design employing a randomized controlled methodology. Patients undergoing gastrointestinal endoscopy and receiving deep sedation were monitored using electronic tracheal sound auscultation. Within this group, patients first underwent a 10-minute session of high-flow nasal oxygen (50 L/min) followed by the utilization of the standard low-flow nasal oxygen (4 L/min). Electronic tracheal sound recordings were obtained during both the high-flow and low-flow nasal oxygen administrations. The aim is to develop an algorithm capable of mitigating the noise generated specifically by the high-flow nasal oxygen.

干预措施: High flow nasal oxygen fist (Device)

HFNO later

Active Comparator

This study follows a crossover design employing a randomized controlled methodology. Patients undergoing gastrointestinal endoscopy and receiving deep sedation were monitored using electronic tracheal sound auscultation. Within this group, patients first underwent a 10-minute session of standard low-flow nasal oxygen (4 L/min) followed by the utilization of the high-flow nasal oxygen (50 L/min). Electronic tracheal sound recordings were obtained during both the high-flow and low-flow nasal oxygen administrations. The aim is to develop an algorithm capable of mitigating the noise generated specifically by the high-flow nasal oxygen

干预措施: High flow nasal oxygen later (Device)

结局指标

主要结局

Tracheal sound with and without high-flow nasal oxygen will be measured to develop an algorithm to mitigate the high flow nasal oxygen-generated tracheal noise

时间窗: 20-30 minutes

We aim to develop an algorithm capable of mitigating the noise generated specifically by the high-flow nasal oxygen based on recording the tracheal sound of patients undergoing gastrointestinal endoscopy in deep sedation with and without high flow nasal oxygen

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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