Evaluation of the Welch Allyn Connex Spot Monitor in Measuring Respiratory Rate in the Emergency Department: a Prospective Observational Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Agreement between respiratory rate values measured by the Welch Allyn Connex Spot Monitor and manual counts performed by trained observers (reference standard)
研究概览
简要总结
This prospective observational study will evaluate the accuracy of the Welch Allyn Connex Spot Monitor equipped with a Masimo SpO₂ finger sensor in measuring respiratory rate in the emergency department. Respiratory rate is a key predictor of patient deterioration, yet it is frequently measured inaccurately when assessed manually. In this study, respiratory rate values obtained by the monitor will be compared against manual counts performed by trained observers (physicians). An additional analysis will compare respiratory rates measured by trained observers with those recorded by triage nurses during triage. A subgroup analysis will also investigate whether cardiac arrhythmias influence measurement accuracy.
The aim is to examine if respiratory rates measured by the Welch Allyn Connex Spot Monitor are comparable to those obtained by trained observers and triage nurses in the emergency department.
详细描述
Design: prospective observational method comparison study
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •- all patients aged ≥18 years.
排除标准
- •patients receiving invasive or non-invasive respiratory support;
- •patients with disorders causing involuntary movements;
- •skin or digit abnormalities preventing proper application of the pulse oximeter;
- •clinically unstable patients on arrival (requiring immediate transfer to the resuscitation area);
- •patients with a left ventricular assist device (LVAD).
结局指标
主要结局
Agreement between respiratory rate values measured by the Welch Allyn Connex Spot Monitor and manual counts performed by trained observers (reference standard)
时间窗: During the emergency department visit (single measurement per participant).
Respiratory rate will be measured simultaneously using the Welch Allyn Connex Spot Monitor and by trained observers performing manual counting over 60 seconds. Agreement between the two methods will be assessed using the Intraclass Correlation Coefficient and Bland-Altman analysis to evaluate bias and limits of agreement.
次要结局
- Agreement between respiratory rate values measured by the Welch Allyn Connex Spot Monitor and manual counts performed by trained observers in patients with ECG-confirmed arrhytmias(During the emergency department visit (single measurement per participant).)
- Agreement between respiratory rate values measured by trained observers and those recorded by triage nurses during triage(During the emergency department visit (single measurement per participant).)
研究者
Dr. Rapszky Gabriella Anna
subinvestigator (PhD student, resident)
Semmelweis University