The Ties That Bind: Evaluation of a Patient-worn Pulse Oximeter Compared to Traditional Pulse Oximetry on Loss of Signal Integrity in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- instances of alarm state corresponding to loss of signal integrity
研究概览
简要总结
This research study will help the investigators to learn more about a device used when children are sick called a pulse oximeter. The pulse oximeter measures how much oxygen is inside a child's blood without taking blood from the child. It is non-invasive meaning it does not enter the body. The device has a cable attached to it. At the end of the cable is a wrap that looks like a Band-Aid with a red light on it. This wrap is placed around a finger or toe. The red light gives the investigators a reading of how much oxygen is in the child's blood and the child's heart rate. Having a pulse oximeter connected to a child is painless. This device is used in many places. Besides hospitals, it is used in doctors' offices and in fitness centers.
This study will help the investigators learn more about whether a partially wireless, more portable pulse oximeter that connects to a small device worn on the child's arm or leg will give the investigators a more reliable signal/reading while letting children move more easily. The investigators will compare this device with the traditional wall-connected unit. Movement of the cable or a child moving may give a false oxygen reading. The investigators will ask the child to do activities that create movement and will look at the readings when the child moves. The investigators think the partially wireless pulse oximeter will be more reliable during movement than the traditional wall-connected unit.
Subjects will have two continuous pulse oximeter probes placed on them. These soft probes will go on a finger, toe, foot or hand and will be attached to two different pulse oximeter monitors. The child will then be asked to do common childhood activities based on their age for about 20 minutes. These activities will be play activities the child already does such as grabbing a toy, drawing with crayons or kicking a ball. Continuous pulse oximetry data will be recorded during the testing and will be stored in a way that it cannot be linked to the subject after the testing is complete.
详细描述
PURPOSE OF THE STUDY This study will evaluate the loss of signal integrity secondary to motion in pediatric subjects being monitored with a newer, partially wireless pulse oximeter (the Radius 7) which eliminates the cable connecting the subject to a wall unit by instead connecting to a small device worn on the subject's arm or leg. The Radius 7 will be compared to the traditional wall-connected pulse oximeter currently used at Children's Hospital of Wisconsin (CHW) which requires a cable connecting to a wall unit (the Radical 7).
HYPOTHESIS Continuously monitoring pulse oximetry with a partially wireless monitor without physical connection to a wall unit will decrease episodes of loss of signal integrity generated by motion artifact in healthy pediatric subjects completing age appropriate activities.
BACKGROUND, SIGNIFICANCE, AND RATIONALE Pulse oximetry is used in both inpatient and outpatient environments to measure the oxygen saturation in a person's blood and the pulse, or heart rate. Pulse oximeters use a painless Band-Aid-like probe that attaches to a fingertip, toe, hand or foot and shines a light through the skin. The monitor then determines how much oxygen is in the blood and the pulse rate based on the way the light passes through the skin. The probe is connected to the monitor by a cable of varying lengths. Movement can cause incorrect pulse oximeter measurements.
Continuous pulse oximetry is considered a standard of care in pediatric intensive care units; however pediatric patients have a high incidence of false alarms in part due to motion artifact. These false alarms contribute to the 94% false alarm incidence in pediatric ICU patients. (Lawless) Motion artifact is potentially exacerbated by the long cables connecting the patients to the continuous monitors. Currently the FDA has not approved any completely cable-free pulse oximeters for continuous use; however Masimo has produced a device (the Radius 7) that overcomes the previously required cable connection to a wall unit via wireless transmission from a patient-worn continuous monitor. (Masimo) There are currently no studies looking at this patient worn monitor in relation to the motion artifacts that frequently cause false alarms in pediatric patients.
The Joint Commission has listed alarm fatigue as a top patient safety concern and as of January 1, 2016 has required hospitals to establish policies and procedures for managing alarm fatigue. Reduction in false alarms is necessary to reduce alarm fatigue. This pilot study will use clinical data to measure the effect of eliminating this cable-to-wall connection on motion artifact. Additionally, early mobility in critically ill patients has been shown to improve outcomes. Freeing patients from one of the cables currently tying them to the room may decrease the false alarms from motion artifact while simultaneously improving mobility, therefore improving patient outcomes and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects between the ages of 6 months and 17 years at the time of data acquisition.
排除标准
- •Subjects will be excluded if they have any pre-existing cardiac or pulmonary chronic medical diagnoses as determined by asking the subject's guardian.
结局指标
主要结局
instances of alarm state corresponding to loss of signal integrity
时间窗: 20 minutes
Loss of signal integrity is defined as complete inability to pick up the patient signal or a change in the pulse oximetry saturation value by 4%.
次要结局
未报告次要终点
研究者
Pamela Petersen
Pediatric Critical Care Fellow
Medical College of Wisconsin