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
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
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
NCT ID
NCT02845011
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
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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