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

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ClinicalTrials.gov Identifier: NCT02845011
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
Shahid Beheshti University
Tehran University of Medical Sciences
East Carolina University
Information provided by (Responsible Party):
Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University

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.

Condition or disease Intervention/treatment Phase
Cardiopulmonary Arrest Cardiopulmonary Resuscitation Device: Audiovisual compression feedback Other: Standard Manual Chest Compression Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Real-time Compression Feedback for Patients With In-hospital Cardiac Arrest: A Multi-Center Randomized Controlled Clinical Trial
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : September 15, 2015
Actual Study Completion Date : December 30, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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 Name: Cardio First Angel™

Active Comparator: Standard chest compression
Cardiopulmonary resuscitation according to international guidelines with standard manual chest compression
Other: Standard Manual Chest Compression
Cardiopulmonary resuscitation according to published international guidelines.




Primary Outcome Measures :
  1. Sustained Return of Spontaneous Circulation [ Time Frame: 30 minutes after completion of cardiopulmonary resuscitation ]
    Return of spontaneous circulation


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845011


Sponsors and Collaborators
Baqiyatallah Medical Sciences University
Shahid Beheshti University
Tehran University of Medical Sciences
East Carolina University
Investigators
Principal Investigator: Amir Vahedian-azimi, PhD, RN Baqiyatallah Universiy of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amir Vahedian-Azimi, PhD, RN, Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier: NCT02845011     History of Changes
Other Study ID Numbers: BMSU CFA Prospective
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

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

Keywords provided by Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University:
Cardio first angle
CPR
Cardiopulmonary Arrest
Clinical trial

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases