NCT02845011

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

9 months

First QC Date

July 21, 2016

Last Update Submit

July 3, 2018

Conditions

Cardiopulmonary ArrestCardiopulmonary Resuscitation

Keywords

Cardio first angleCPRCardiopulmonary ArrestClinical trial

Outcome Measures

Primary Outcomes (1)

  • Sustained Return of Spontaneous Circulation

    Return of spontaneous circulation

    30 minutes after completion of cardiopulmonary resuscitation

Secondary Outcomes (3)

  • Survival to ICU discharge

    through ICU discharge, usually 15-35 days

  • Survival to Hospital Discharge

    through study completion, usually 30-45 days

  • Fractures

    through study completion, usually less than 60 days

Study Arms (2)

Audiovisual compression feedback

EXPERIMENTAL

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

Standard chest compression

ACTIVE COMPARATOR

Cardiopulmonary resuscitation according to international guidelines with standard manual chest compression

Other: Standard Manual Chest Compression

Interventions

Audiovisual compression feedbackDEVICE

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™
Audiovisual compression feedback
Standard Manual Chest CompressionOTHER

Cardiopulmonary resuscitation according to published international guidelines.

Standard chest compression

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30693086DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Amir Vahedian-azimi, PhD, RN

    Baqiyatallah Universiy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The clinical provider was not involved in the study. S(he) was not blind during the resuscitation as they could see device, and it was not considered ethical to employ a sham device.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, RN

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 26, 2016

Study Start

January 1, 2015

Primary Completion

September 15, 2015

Study Completion

December 30, 2015

Last Updated

July 6, 2018

Record last verified: 2018-07