Effect of the Cardio First Angle Device on CPR Outcomes (CFA)

July 2, 2018 updated by: Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University

Pilot Study of the Effect of Cardio First Angel (CFA) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Compression with Feedback
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.
Device: Compression with Feedback
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™
Active Comparator: Standard chest compression
CPR performed according to established international standards with standard manual chest compression
Other: Standard chest compression
CPR in accordance with published international guidelines using standard manual chest compression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Return of Spontaneous Circulation
Time Frame: through resuscitation completion, an average of 30 to 60 minutes
ROSC lasting > 30 minutes
through resuscitation completion, an average of 30 to 60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nurse Satisfaction Score
Time Frame: upon resuscitation completion, an average of 30 to 60 minutes
Nurse satisfaction with resuscitation event using a validated tool
upon resuscitation completion, an average of 30 to 60 minutes
CPR Duration
Time Frame: through resuscitation completion, an average of 30 to 60 minutes
Duration of CPR event
through resuscitation completion, an average of 30 to 60 minutes
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
through resuscitation completion, an average of 30 to 60 minutes
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
upon resuscitation completion, an average of 30 to 60 minutes
CPR Guideline Observation Score
Time Frame: upon resuscitation completion, an average of 30 to 60 minutes
Assesses guideline adherence
upon resuscitation completion, an average of 30 to 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baqiyatallah Medical Sciences University

Collaborators

Shahid Beheshti University of Medical Sciences
West Virginia University

Investigators

  • Principal Investigator: Amir vahedian-azimi, PhD, RN, BMSU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMSU-390-5-5904

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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