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

Primary Purpose

Cardiopulmonary Arrest, Cardiopulmonary Resuscitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Audiovisual compression feedback
Standard Manual Chest Compression
Sponsored by
Baqiyatallah Medical Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiopulmonary Arrest focused on measuring Cardio first angle, CPR, Cardiopulmonary Arrest, Clinical trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Audiovisual compression feedback

    Standard chest compression

    Arm Description

    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.

    Cardiopulmonary resuscitation according to international guidelines with standard manual chest compression

    Outcomes

    Primary Outcome Measures

    Sustained Return of Spontaneous Circulation
    Return of spontaneous circulation

    Secondary Outcome Measures

    Survival to ICU discharge
    Survival to first or only ICU discharge
    Survival to Hospital Discharge
    Survival to Hospital Discharge
    Fractures
    Number of rib or sternum fractures

    Full Information

    First Posted
    July 21, 2016
    Last Updated
    July 3, 2018
    Sponsor
    Baqiyatallah Medical Sciences University
    Collaborators
    Shahid Beheshti University, Tehran University of Medical Sciences, East Carolina University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02845011
    Brief Title
    Compression Feedback for Patients With In-hospital Cardiac Arrest
    Acronym
    CFA
    Official Title
    Real-time Compression Feedback for Patients With In-hospital Cardiac Arrest: A Multi-Center Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    September 15, 2015 (Actual)
    Study Completion Date
    December 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baqiyatallah Medical Sciences University
    Collaborators
    Shahid Beheshti University, Tehran University of Medical Sciences, East Carolina University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiopulmonary Arrest, Cardiopulmonary Resuscitation
    Keywords
    Cardio first angle, CPR, Cardiopulmonary Arrest, Clinical trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    900 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Audiovisual compression feedback
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard chest compression
    Arm Type
    Active Comparator
    Arm Description
    Cardiopulmonary resuscitation according to international guidelines with standard manual chest compression
    Intervention Type
    Device
    Intervention Name(s)
    Audiovisual compression feedback
    Other Intervention Name(s)
    Cardio First Angel™
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Standard Manual Chest Compression
    Intervention Description
    Cardiopulmonary resuscitation according to published international guidelines.
    Primary Outcome Measure Information:
    Title
    Sustained Return of Spontaneous Circulation
    Description
    Return of spontaneous circulation
    Time Frame
    30 minutes after completion of cardiopulmonary resuscitation
    Secondary Outcome Measure Information:
    Title
    Survival to ICU discharge
    Description
    Survival to first or only ICU discharge
    Time Frame
    through ICU discharge, usually 15-35 days
    Title
    Survival to Hospital Discharge
    Description
    Survival to Hospital Discharge
    Time Frame
    through study completion, usually 30-45 days
    Title
    Fractures
    Description
    Number of rib or sternum fractures
    Time Frame
    through study completion, usually less than 60 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amir Vahedian-azimi, PhD, RN
    Organizational Affiliation
    Baqiyatallah Universiy of Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30693086
    Citation
    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.
    Results Reference
    derived

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    Compression Feedback for Patients With In-hospital Cardiac Arrest

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