Skip to main content
OpenTrials
Completed

NCT Number: NCT02394977

Effect of the Cardio First Angle Device on CPR Outcomes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiopulmonary Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Compression with Feedback

Device

Patients in the intervention group received CPR in accordance to published guidelines using the CFA device per manufacturer instructions. The Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) is a lightweight device that consists of three components . Application of400 ± 30 Newtons of force (41 kg or 90 lb of pressure), which correlates toa sternum compression depth of 50-60 mm, is followed by an audible "click" sound to alert the rescuer to cease compression. The "click" sound is also audible upon spring decompression alerting the rescuer to resume compression. The device does not require an electrical power supply.

Other names: Cardio First Angel™

Standard chest compression

Other

CPR in accordance with published international guidelines using standard manual chest compression.

Primary outcomes

  1. Sustained Return of Spontaneous Circulation

    Time frame: through resuscitation completion, an average of 30 to 60 minutes

    ROSC lasting > 30 minutes

Secondary outcomes

  1. Nurse Satisfaction Score

    Time frame: upon resuscitation completion, an average of 30 to 60 minutes

    Nurse satisfaction with resuscitation event using a validated tool

  2. CPR Duration

    Time frame: through resuscitation completion, an average of 30 to 60 minutes

    Duration of CPR event

  3. New post-resuscitation Sternum or Rib Fractures

    Time frame: through resuscitation completion, an average of 30 to 60 minutes

    New sternum or Rib Fractures diagnosed post-resuscitation using X-ray, CT scan, or by Autopsy

  4. CPR Evaluation Score

    Time frame: upon resuscitation completion, an average of 30 to 60 minutes

    CPR evaluation score assess quality of CPR including chest compression sing a validated tool

  5. CPR Guideline Observation Score

    Time frame: upon resuscitation completion, an average of 30 to 60 minutes

    Assesses guideline adherence

Sponsors and collaborators

Lead sponsor

Baqiyatallah Medical Sciences University

Other

Collaborators

  • Shahid Beheshti University of Medical Sciences
  • West Virginia University

Registry information

Official study title

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

Acronym: CFA

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 20, 2015
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.