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临床试验/NCT05991843
NCT05991843已完成不适用

Is it Possible to Measure an Adequate Respiration Rate Using Pressure Variation During HFNC

Rijnstate Hospital2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Respiratory rate by manual count

研究概览

简要总结

Monitoring the respiratory rate is important during procedural sedation. Several methods of measuring the respiratory rate are available, but most are unreliable and the most reliable method (capnography) is not available during the use of High Flow Nasal Cannula (HFNC) oxygen. We hypothesize that measuring the pressure variation in the HFNC-circuit is a reliable method of measuring the respiratory rate.

An experimental study, using healthy volunteers that will breath in three guided respiratory rates, compares the measurements of respiratory rate by the pressure variation in the HFNC circuit with measurements of respiratory rate by an ECG-derived method and a manual count by an physician.

A secondary outcome will be the ability to measure the size of pressure difference, in order to determine its feasiblity to use it as a surrogate for tidal volume or respiratory effort.

详细描述

The healthy volunteers will be administered HFNC-oxygen and will be instructed to breath normally, rapidly and slowly for 30 seconds. This will be done at two HFNC flow rates (35 L/min and 70 L/min) and with an open and a closed mouth. During these 30 seconds the respiratory rate will be measured by pressure variation in the HFNC circuit, ECG-derived impedance difference and a manual count by a physician.

This will lead to 12 conditions, depending on HFNC flow (35 and 70 L/min), open or closed mouth and respiratory rate (normally, rapidly, slowly). The measurements of the respiratory rates wil be compared per HFNC flow and per open or closed mouth.

A secondary outcome will be the ability to measure the size of pressure difference, in order to determine its feasiblity to use it as a surrogate for tidal volume or respiratory effort.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • healthy volunteers

排除标准

  • known neurodegenerative diseases
  • Pregnancy
  • Children (age <18)
  • Upper airway obstruction

结局指标

主要结局

Respiratory rate by manual count

时间窗: 30 seconds

Respiratory rate as measured by a physician

Respiratory rate by pressure variation

时间窗: 30 seconds

Respiratory rate as measured by the pressure variation in the HFNC circuit.

Respiratory rate by ECG-derived measurement

时间窗: 30 seconds.

Respiratory rate as measured by the ECG-derived impedance difference

次要结局

  • Pressure difference during breathing(30 seconds.)

研究者

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Koning

Anesthesiologist-intensivist, principal investigator

Rijnstate Hospital

研究点 (2)

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