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Effect of the Cardio First Angle Device on CPR Outcomes (CFA)

Primary Purpose

Cardiopulmonary Arrest

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compression with Feedback
Standard chest compression
Sponsored by
Baqiyatallah Medical Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

    Compression with Feedback

    Standard chest compression

    Arm Description

    CPR performed according to established international standards with chest compressions performed with the assistance of the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) compression feedback device.

    CPR performed according to established international standards with standard manual chest compression

    Outcomes

    Primary Outcome Measures

    Sustained Return of Spontaneous Circulation
    ROSC lasting > 30 minutes

    Secondary Outcome Measures

    Nurse Satisfaction Score
    Nurse satisfaction with resuscitation event using a validated tool
    CPR Duration
    Duration of CPR event
    New post-resuscitation Sternum or Rib Fractures
    New sternum or Rib Fractures diagnosed post-resuscitation using X-ray, CT scan, or by Autopsy
    CPR Evaluation Score
    CPR evaluation score assess quality of CPR including chest compression sing a validated tool
    CPR Guideline Observation Score
    Assesses guideline adherence

    Full Information

    First Posted
    March 5, 2015
    Last Updated
    July 2, 2018
    Sponsor
    Baqiyatallah Medical Sciences University
    Collaborators
    Shahid Beheshti University of Medical Sciences, West Virginia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02394977
    Brief Title
    Effect of the Cardio First Angle Device on CPR Outcomes
    Acronym
    CFA
    Official Title
    Pilot Study of the Effect of Cardio First Angel (CFA) Device on CPR Outcomes:
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baqiyatallah Medical Sciences University
    Collaborators
    Shahid Beheshti University of Medical Sciences, West Virginia University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators conducted a randomized, controlled, single-blinded study of patients undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic teaching hospitals in Tehran, Iran from June 1 to October 31, 2014. Patients were randomized to receive CPR with either standard manual compression, or compression with real-time audiovisual feedback using the Cardio First Angel™ device.
    Detailed Description
    The investigators sought to determine if the addition of a CPR feedback device to routine manual CPR would impact the quality and consistency of chest compression and patient survival. We conducted a randomized, controlled, single-blinded study of patients undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic teaching hospitals. Patients were randomized to receive either standard manual CPR or CPR using the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) feedback device. Recorded variables included return of spontaneous circulation, adherence to CPR guidelines and quality of CPR, nurse satisfaction and CPR associated morbidity.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Compression with Feedback
    Arm Type
    Experimental
    Arm Description
    CPR performed according to established international standards with chest compressions performed with the assistance of the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) compression feedback device.
    Arm Title
    Standard chest compression
    Arm Type
    Active Comparator
    Arm Description
    CPR performed according to established international standards with standard manual chest compression
    Intervention Type
    Device
    Intervention Name(s)
    Compression with Feedback
    Other Intervention Name(s)
    Cardio First Angel™
    Intervention Description
    Patients in the intervention group received CPR in accordance to published guidelines using the CFA device per manufacturer instructions. The Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) is a lightweight device that consists of three components . Application of400 ± 30 Newtons of force (41 kg or 90 lb of pressure), which correlates toa sternum compression depth of 50-60 mm, is followed by an audible "click" sound to alert the rescuer to cease compression. The "click" sound is also audible upon spring decompression alerting the rescuer to resume compression. The device does not require an electrical power supply.
    Intervention Type
    Other
    Intervention Name(s)
    Standard chest compression
    Intervention Description
    CPR in accordance with published international guidelines using standard manual chest compression.
    Primary Outcome Measure Information:
    Title
    Sustained Return of Spontaneous Circulation
    Description
    ROSC lasting > 30 minutes
    Time Frame
    through resuscitation completion, an average of 30 to 60 minutes
    Secondary Outcome Measure Information:
    Title
    Nurse Satisfaction Score
    Description
    Nurse satisfaction with resuscitation event using a validated tool
    Time Frame
    upon resuscitation completion, an average of 30 to 60 minutes
    Title
    CPR Duration
    Description
    Duration of CPR event
    Time Frame
    through resuscitation completion, an average of 30 to 60 minutes
    Title
    New post-resuscitation Sternum or Rib Fractures
    Description
    New sternum or Rib Fractures diagnosed post-resuscitation using X-ray, CT scan, or by Autopsy
    Time Frame
    through resuscitation completion, an average of 30 to 60 minutes
    Title
    CPR Evaluation Score
    Description
    CPR evaluation score assess quality of CPR including chest compression sing a validated tool
    Time Frame
    upon resuscitation completion, an average of 30 to 60 minutes
    Title
    CPR Guideline Observation Score
    Description
    Assesses guideline adherence
    Time Frame
    upon resuscitation completion, an average of 30 to 60 minutes

    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
    BMSU
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27184664
    Citation
    Vahedian-Azimi A, Hajiesmaeili M, Amirsavadkouhi A, Jamaati H, Izadi M, Madani SJ, Hashemian SM, Miller AC. Effect of the Cardio First Angel device on CPR indices: a randomized controlled clinical trial. Crit Care. 2016 May 17;20(1):147. doi: 10.1186/s13054-016-1296-3.
    Results Reference
    result
    Links:
    URL
    http://ccforum.biomedcentral.com/articles/10.1186/s13054-016-1296-3#Sec11
    Description
    "Critical Care" site for full text

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    Effect of the Cardio First Angle Device on CPR Outcomes

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