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
|Condition or disease||Intervention/treatment||Phase|
|Cardiopulmonary Arrest Cardiopulmonary Resuscitation||Device: Audiovisual compression feedback Other: Standard Manual Chest Compression||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||900 participants|
|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.|
|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|
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.
- Sustained Return of Spontaneous Circulation [ Time Frame: 30 minutes after completion of cardiopulmonary resuscitation ]Return of spontaneous circulation
- Survival to ICU discharge [ Time Frame: through ICU discharge, usually 15-35 days ]Survival to first or only ICU discharge
- Survival to Hospital Discharge [ Time Frame: through study completion, usually 30-45 days ]Survival to Hospital Discharge
- Fractures [ Time Frame: through study completion, usually less than 60 days ]Number of rib or sternum fractures
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
|Principal Investigator:||Amir Vahedian-azimi, PhD, RN||Baqiyatallah Universiy of Medical Sciences|