跳至主要内容
临床试验/NCT02394977
NCT02394977已完成不适用

Pilot Study of the Effect of Cardio First Angel (CFA) Device on CPR Outcomes:

Baqiyatallah Medical Sciences University0 个研究点目标入组 80 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
主要终点
Sustained Return of Spontaneous Circulation

研究概览

简要总结

The investigators conducted a randomized, controlled, single-blinded study of patients undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic teaching hospitals in Tehran, Iran from June 1 to October 31, 2014. Patients were randomized to receive CPR with either standard manual compression, or compression with real-time audiovisual feedback using the Cardio First Angel™ device.

详细描述

The investigators sought to determine if the addition of a CPR feedback device to routine manual CPR would impact the quality and consistency of chest compression and patient survival. We conducted a randomized, controlled, single-blinded study of patients undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic teaching hospitals. Patients were randomized to receive either standard manual CPR or CPR using the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) feedback device. Recorded variables included return of spontaneous circulation, adherence to CPR guidelines and quality of CPR, nurse satisfaction and CPR associated morbidity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Admitted to the intensive care unit (ICU)
  • Full-code status
  • Informed consent was obtained from the patient, legal guardian, or healthcare surrogate upon ICU admission (prior to cardiac arrest event)

排除标准

  • Patients with any limitation of code status including but not limited to "no code" or"do not resuscitate" (DNR) and"do not intubate" (DNI), were excluded from study participation

研究组 & 干预措施

Compression with Feedback

Experimental

CPR performed according to established international standards with chest compressions performed with the assistance of the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) compression feedback device.

干预措施: Compression with Feedback (Device)

Standard chest compression

Active Comparator

CPR performed according to established international standards with standard manual chest compression

干预措施: Standard chest compression (Other)

结局指标

主要结局

Sustained Return of Spontaneous Circulation

时间窗: through resuscitation completion, an average of 30 to 60 minutes

ROSC lasting \> 30 minutes

次要结局

  • CPR Duration(through resuscitation completion, an average of 30 to 60 minutes)
  • Nurse Satisfaction Score(upon resuscitation completion, an average of 30 to 60 minutes)
  • New post-resuscitation Sternum or Rib Fractures(through resuscitation completion, an average of 30 to 60 minutes)
  • CPR Evaluation Score(upon resuscitation completion, an average of 30 to 60 minutes)
  • CPR Guideline Observation Score(upon resuscitation completion, an average of 30 to 60 minutes)

研究者

发起方
Baqiyatallah Medical Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amir Vahedian-Azimi

Senior intensivist nurse, Respiratory therapist, Research Fellow, PhD, RN, FCCS

Baqiyatallah Medical Sciences University

相似试验