ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02394977
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : July 4, 2018
Sponsor:
Collaborators:
Shahid Beheshti University of Medical Sciences
West Virginia University
Information provided by (Responsible Party):
Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University

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.

Condition or disease Intervention/treatment Phase
Cardiopulmonary Arrest Device: Compression with Feedback Other: Standard chest compression Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pilot Study of the Effect of Cardio First Angel (CFA) Device on CPR Outcomes:
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Compression with Feedback
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.
Device: Compression with Feedback
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.
Other Name: Cardio First Angel™

Active Comparator: Standard chest compression
CPR performed according to established international standards with standard manual chest compression
Other: Standard chest compression
CPR in accordance with published international guidelines using standard manual chest compression.




Primary Outcome Measures :
  1. Sustained Return of Spontaneous Circulation [ Time Frame: through resuscitation completion, an average of 30 to 60 minutes ]
    ROSC lasting > 30 minutes


Secondary Outcome Measures :
  1. Nurse Satisfaction Score [ Time Frame: upon resuscitation completion, an average of 30 to 60 minutes ]
    Nurse satisfaction with resuscitation event using a validated tool

  2. CPR Duration [ Time Frame: through resuscitation completion, an average of 30 to 60 minutes ]
    Duration of CPR event

  3. New post-resuscitation Sternum or Rib Fractures [ Time Frame: through resuscitation completion, an average of 30 to 60 minutes ]
    New sternum or Rib Fractures diagnosed post-resuscitation using X-ray, CT scan, or by Autopsy

  4. CPR Evaluation Score [ Time Frame: upon resuscitation completion, an average of 30 to 60 minutes ]
    CPR evaluation score assess quality of CPR including chest compression sing a validated tool

  5. CPR Guideline Observation Score [ Time Frame: upon resuscitation completion, an average of 30 to 60 minutes ]
    Assesses guideline adherence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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): NCT02394977


Sponsors and Collaborators
Baqiyatallah Medical Sciences University
Shahid Beheshti University of Medical Sciences
West Virginia University
Investigators
Principal Investigator: Amir vahedian-azimi, PhD, RN BMSU

Additional Information:
Publications of Results:
Responsible Party: Amir Vahedian-Azimi, Senior intensivist nurse, Respiratory therapist, Research Fellow, PhD, RN, FCCS, Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier: NCT02394977     History of Changes
Other Study ID Numbers: BMSU-390-5-5904
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases