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Completed

NCT Number: NCT02845011

Compression Feedback for Patients With In-hospital Cardiac Arrest

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.

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Key information

Conditions

Cardiopulmonary Arrest Cardiopulmonary Resuscitation 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

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.

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

Audiovisual compression feedback

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™

Standard Manual Chest Compression

Other

Cardiopulmonary resuscitation according to published international guidelines.

Primary outcomes

  1. Sustained Return of Spontaneous Circulation

    Time frame: 30 minutes after completion of cardiopulmonary resuscitation

    Return of spontaneous circulation

Secondary outcomes

  1. Survival to ICU discharge

    Time frame: through ICU discharge, usually 15-35 days

    Survival to first or only ICU discharge

  2. Survival to Hospital Discharge

    Time frame: through study completion, usually 30-45 days

    Survival to Hospital Discharge

  3. Fractures

    Time frame: through study completion, usually less than 60 days

    Number of rib or sternum fractures

Sponsors and collaborators

Lead sponsor

Baqiyatallah Medical Sciences University

Other

Collaborators

  • East Carolina University
  • Shahid Beheshti University
  • Tehran University of Medical Sciences

Registry information

Official study title

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

Acronym: CFA

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 26, 2016
Registry last updated
Jul 6, 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.

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