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CompletedNCT02845011CFAUpdated Jul 6, 2018

Compression Feedback for Patients With In-hospital Cardiac Arrest

An interventional study of Audiovisual compression feedback and Standard Manual Chest Compression in Cardiopulmonary Arrest and Cardiopulmonary Resuscitation, sponsored by Baqiyatallah Medical Sciences University. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-07-06.

Sponsored by Baqiyatallah Medical Sciences University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jan 2015, registered Jul 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Cardiopulmonary Arrest
  • Cardiopulmonary Resuscitation

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Keywords

  • Cardio first angle
  • CPR
  • Cardiopulmonary Arrest
  • Clinical trial
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In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's enrollment of 900 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Baqiyatallah Medical Sciences University is the lead sponsor of 31 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
900 participants (actual)

Study arms

  • 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.

    Device: Audiovisual compression feedback

  • Active comparator
    Standard chest compression

    Cardiopulmonary resuscitation according to international guidelines with standard manual chest compression

    Other: Standard Manual Chest Compression

Interventions

  • DeviceAudiovisual compression feedback

    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.

    Also known as: Cardio First Angel™

  • OtherStandard Manual Chest Compression

    Cardiopulmonary resuscitation according to published international guidelines.

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What researchers measure

Primary outcomes

  1. Sustained Return of Spontaneous Circulation

    Return of spontaneous circulation

    Time frame: 30 minutes after completion of cardiopulmonary resuscitation

Secondary outcomes

  1. Survival to ICU discharge

    Survival to first or only ICU discharge

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

  2. Survival to Hospital Discharge

    Survival to Hospital Discharge

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

  3. Fractures

    Number of rib or sternum fractures

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Goharani R, Vahedian-Azimi A, Farzanegan B, Bashar FR, Hajiesmaeili M, Shojaei S, Madani SJ, Gohari-Moghaddam K, Hatamian S, Mosavinasab SMM, Khoshfetrat M, Khabiri Khatir MA, Miller AC; MORZAK Collaborative. Real-time compression feedback for patients with in-hospital cardiac arrest: a multi-center randomized controlled clinical trial. J Intensive Care. 2019 Jan 22;7:5. doi: 10.1186/s40560-019-0357-5. eCollection 2019. PubMed 30693086 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02845011
Lead sponsor
Baqiyatallah Medical Sciences University
Collaborators
Shahid Beheshti University, Tehran University of Medical Sciences, East Carolina University
Responsible party
Amir Vahedian-Azimi (PhD, RN, Baqiyatallah Medical Sciences University) — Principal investigator
First posted
Jul 26, 2016
Start date
Jan 1, 2015
Primary completion
Sep 15, 2015
Completion
Dec 30, 2015
Last update
Jul 6, 2018

Study contacts

Amir Vahedian-azimi, PhD, RN
principal investigator · Baqiyatallah Universiy of Medical Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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