Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care
研究概览
简要总结
A randomized controlled trial compared the clinical outcomes of transported pediatric patients monitored with an oscillometric blood pressure device versus those monitored with a near-continuous, noninvasive blood pressure.
详细描述
94 transported patients were randomized to a control arm, monitored with a standard oscillometric blood pressure device (Dinamap), or an experimental arm, monitored with a near-continuous, noninvasive blood pressure device (Vasotrac).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients transported by Angel One to Arkansas Children's Hospital.
- •Age Group: 1 year - 17 years AND
- •Patients at risk of developing SIRS (Systemic Inflammatory Response Syndrome), according to the criteria below.
- •i. The presence of at least two of the following four criteria (one of which must be abnormal temperature or leukocyte count): A. Core temperature of >38.5 C or <36 C. B. Tachycardia, defined as mean heart rate >95th percentile for age in absence of external stimulus, chronic drugs, or painful stimuli.
- •C. Mean respiratory rate >95th percentile for age, or >10% immature neutrophils.
- •Patients with moderate or severe head trauma, at risk of developing secondary ischemic brain injury, according to the criteria below.
- •i. Glasgow Coma scale <15 with one or more of the following: A. Mass lesion or cerebral edema on CT or MRI scan. B. Post-Traumatic Seizure. C. Multiple Trauma. D. Focal Neurologic Signs. E. Intubation for control of suspected intracranial hypertension.
排除标准
- •Wrist circumference less than 11cm (minimum size for the Vasotrac device).
- •Contractures of the wrists, not allowing correct placement of the Vasotrac device.
- •Hematoma(s) located on both wrists from recent redial (<24hr) artery puncture.
- •Patients likely to proceed to brain death per assessment of the referring physician.
- •Patients being treated for malignant hypertension.
研究组 & 干预措施
Continuous Blood Pressure Monitoring
Patients received continuous blood pressure monitoring the entire time they were in med flight to the hospital.
干预措施: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device (Device)
Standard of care blood pressure monitoring
Patients received the normal standard of care for blood pressure monitoring during the course of the med flight to the hospital.
干预措施: Standard of care blood pressure monitoring (Device)
结局指标
主要结局
The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care
时间窗: Up to two weeks
This is the total number of participants analyzed for the intervention group and the total number of participants analyzed for the control group and the total number of days that each group was analyzed overall.
次要结局
- Intensive Care Unit (ICU) Length of Stay(Up to two weeks)
- Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale.(Up to two weeks)
- Amount of Intravenous Fluid Resuscitation(At start of inter-facility transport, then every 15 minutes until arrival.)
- Total Number of Organ Failure Days (Multiple Organ Dysfunction) in the Intensive Care Unit (ICU)for the Control Group and Total Number of Organ Failure Days for the Intervention Group. Multiple Organ Dysfunction is Defined as Multiple Organ Failure.(Up to two weeks)