Compression Feedback for Patients With In-hospital Cardiac Arrest (CFA)

July 3, 2018 updated by: Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University

Real-time Compression Feedback for Patients With In-hospital Cardiac Arrest: A Multi-Center Randomized Controlled Clinical Trial

A prospective, randomized, controlled, parallel study was conducted in patients undergoing resuscitation with chest compression for in-hospital cardiac arrest (IHCA) in the mixed medical-surgical ICU's of 8 academic tertiary care hospitals in Iran. Patients randomized into 2 groups: 1) standard chest compression, 2) chest compression with real-time audio-visual feedback using the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) device. The primary outcome was sustained return of spontaneous circulation (ROSC). Secondary outcomes were survival to ICU and hospital discharge, incidence of sternum and rib fractures.

Study Overview

Detailed Description

A prospective, randomized, controlled, parallel study was conducted in patients undergoing resuscitation with chest compression for in-hospital cardiac arrest (IHCA) in the mixed medical-surgical ICU's of 8 academic tertiary care hospitals in Iran. Patients randomized into 2 groups: 1) standard chest compression, 2) chest compression with real-time audio-visual feedback using the Cardio First Angel™ (INOTECH, Nubberg, Germany) device. Randomization accomplished using Random Allocation Software© (RAS; Informer Technologies, Inc., Madrid, Spain). Crossover was not allowed. The patient and data analyzer were blinded. The clinical provider was not blinded. The primary outcome was sustained return of spontaneous circulation (ROSC). Secondary outcomes were survival to ICU and hospital discharge, incidence of sternum and rib fractures.

Study Type

Interventional

Enrollment (Actual)

900

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Audiovisual compression feedback
Cardiopulmonary resuscitation according to international guidelines with chest compressions performed with real-time audiovisual feedback using the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) device.
The Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) is a handheld device consisting of three components. The rescuer-side has a red palm-sized push-button with a pictogram illustrating proper use. The center unit is composed of a stable plastic base containing an arrangement of springs, and the patient-side consists of liquid-absorbent polyurethane foam. Application of 400 ± 30 Newtons of force results in an audible click alerting the rescuer to cease compression, and an additional click on decompression alerts the rescuer to resume compression.
Other Names:
  • Cardio First Angel™
Active Comparator: Standard chest compression
Cardiopulmonary resuscitation according to international guidelines with standard manual chest compression
Cardiopulmonary resuscitation according to published international guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Return of Spontaneous Circulation
Time Frame: 30 minutes after completion of cardiopulmonary resuscitation
Return of spontaneous circulation
30 minutes after completion of cardiopulmonary resuscitation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival to ICU discharge
Time Frame: through ICU discharge, usually 15-35 days
Survival to first or only ICU discharge
through ICU discharge, usually 15-35 days
Survival to Hospital Discharge
Time Frame: through study completion, usually 30-45 days
Survival to Hospital Discharge
through study completion, usually 30-45 days
Fractures
Time Frame: through study completion, usually less than 60 days
Number of rib or sternum fractures
through study completion, usually less than 60 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Amir Vahedian-azimi, PhD, RN, Baqiyatallah Universiy of Medical Sciences

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.

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 (Actual)

January 1, 2015

Primary Completion (Actual)

September 15, 2015

Study Completion (Actual)

December 30, 2015

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMSU CFA Prospective

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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