- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02845011
Compression Feedback for Patients With In-hospital Cardiac Arrest (CFA)
July 3, 2018 updated by: Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University
Real-time Compression Feedback for Patients With In-hospital Cardiac Arrest: A Multi-Center Randomized Controlled Clinical Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment (Actual)
900
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
Active Comparator: Standard chest compression
Cardiopulmonary resuscitation according to international guidelines with standard manual chest compression
|
Cardiopulmonary resuscitation according to published international guidelines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained Return of Spontaneous Circulation
Time Frame: 30 minutes after completion of cardiopulmonary resuscitation
|
Return of spontaneous circulation
|
30 minutes after completion of cardiopulmonary resuscitation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival to ICU discharge
Time Frame: through ICU discharge, usually 15-35 days
|
Survival to first or only ICU discharge
|
through ICU discharge, usually 15-35 days
|
Survival to Hospital Discharge
Time Frame: through study completion, usually 30-45 days
|
Survival to Hospital Discharge
|
through study completion, usually 30-45 days
|
Fractures
Time Frame: through study completion, usually less than 60 days
|
Number of rib or sternum fractures
|
through study completion, usually less than 60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Amir Vahedian-azimi, PhD, RN, Baqiyatallah Universiy of Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
September 15, 2015
Study Completion (Actual)
December 30, 2015
Study Registration Dates
First Submitted
July 21, 2016
First Submitted That Met QC Criteria
July 22, 2016
First Posted (Estimate)
July 26, 2016
Study Record Updates
Last Update Posted (Actual)
July 6, 2018
Last Update Submitted That Met QC Criteria
July 3, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMSU CFA Prospective
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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