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临床试验/NCT05588024
NCT05588024招募中不适用

International Device Assisted Controlled Sequential Elevation CPR Registry

Hennepin Healthcare Research Institute1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2020年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
Survival with Favorable Neurological Function

研究概览

简要总结

The purpose of this prospective observational cardiopulmonary resuscitation (CPR) registry is to track the use and clinical outcomes from emergency medical systems across the US and Europe that have implemented a system of care approach applied rapidly to cardiac arrest that includes using the combination of an impedance threshold device (ITD), and either manual active compression-decompression (ACD) CPR device or automated compression device, with a Head Up CPR device.

详细描述

In 2019, a FDA approved patient positioning device capable of elevating the head and thorax in a controlled manner became commercially available. As emergency medical services are increasingly using this Head Up CPR patient positioning device as part of their standard protocol for cardiac arrest patients, in addition to Active Compression-Decompression (ACD) cardiopulmonary resuscitation with an Impedance Threshold Device (ITD) CPR or with mechanical CPR and the ITD, it is important to monitor how this device is being used, and outcomes of patients who received this Head Up CPR therapy. All of the devices used in this observational registry study have received FDA 510K clearance.

Emergency medical systems (EMS) that have implemented standard cardiac arrest protocols that include the combination of manual CPR with an ITD, an automated CPR device with the ITD, or ACD+ITD CPR, with the Head Up CPR device are asked to be part of the Registry. If a system participates, they are asked for de-identified cardiac arrest data including patient demographics, details of cardiac arrest care, and patient outcomes before and after implementation of the Head Up CPR bundle. De-identified data is kept securely by the study sponsor and PI. The patient data for all systems using this approach to resuscitation are included, with a current focus on patients receiving the device combination rapidly.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Survival with Favorable Neurological Function

时间窗: The time period in which this outcome will occur will vary, may extend up to 60 days.

If the patient survived admission to the hospital until hospital discharge with favorable Cerebral Performance Category (CPC) Score as defined CPC 1 or 2.

Return of Spontaneous Circulation

时间窗: From the start of CPR to the presence of cardiac activity. The time period in which this outcome will varies and is estimated to range from 0 minutes up to around 40 minutes.

Presence of cardiac activity with a perfusing blood pressure

Survival

时间窗: The time period in which this outcome will occur will vary, may extend up to 60 days.

If the patient survived admission to the hospital until hospital discharge

次要结局

  • End tidal CO2 (ETCO2)(ETCO2 will be measured continuously while the patient is receiving CPR. This time period is estimated to occur up to 40 minutes.)
  • Cerebral Oximetry(If the participating EMS system in the registry uses NIRS cerebral oximetry, it will be measured continuously while the patient is receiving CPR. This time period is estimated to occur up to 40 minutes.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Johanna Moore

Johanna Moore, MD MSc

Hennepin Healthcare Research Institute

研究点 (1)

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