An Evaluation of Plethysmography-based Trending of Respiratory Rate Using the Nellcor™ Bedside Respiratory Patient Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Agreement of RR measured by spot checks vs continuous monitoring
研究概览
简要总结
This is an open-label, non-randomized, prospective, descriptive study of the Nellcor™ Bedside Respiratory Patient Monitoring System using the Nellcor™ Respiration Rate parameter and Nellcor™ Adult Respiratory Sensor The study is intended to gain further information in the clinical space on the function of the Nellcor™ Respiration Rate parameter. The primary objective is to describe spot check (e.g. manual observation) of respiration rate versus cumulative automated counting (trend) of respiratory rate as measured using the Nellcor™ Bedside Respiratory Patient Monitoring System with the Nellcor™ Respiration Rate parameter.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •18 years or older.
- •A patient who meets the weight requirement for the sensor (e.g. >30kg).
- •A patient at the study site on a General Care Floor (surgical or medical/non-surgical to be distributed equally) and prescribed standard vital sign checks.
- •Patient is willing and able to provide written informed consent.
排除标准
- •Expected length of stay is < 4 hours.
- •Patient is pregnant or lactating.
- •Patient has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
- •Patient has an abnormality that may prevent proper application of the device.
- •Patient is in atrial fibrillation.
- •Patient has a documented history of frequent premature atrial contractions (PACs) or premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds within the past 3 months.
- •Patient has an implanted pacemaker.
- •Patient has excessive nail polish that cannot be removed or other dye or discoloration of the finger.
- •Patient has diagnosed central apnea or diagnosed significant obstructive sleep apnea.
- •Patient is currently using continuous positive airway pressure (CPAP).
- •Patient is unwilling or unable to sign informed consent.
- •Evidence that the patient cannot understand the purpose and risks of the study and would require a legally authorized representative to sign informed consent.
- •Patient is participating in another potentially confounding clinical study.
- •Extreme motion conditions such as patient is prescribed to walk more than once per hour or is prescribed a medical device resulting in constant movement.
结局指标
主要结局
Agreement of RR measured by spot checks vs continuous monitoring
时间窗: at least 4 hours
Bias and a range of agreement of the differences between RR measured by spot checks and RR measured using the Nellcor™ Bedside Respiratory Patient Monitoring System
次要结局
未报告次要终点