Compression Feedback for Patients With In-hospital Cardiac Arrest

Study Overview
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Brief Summary
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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
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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.

Official Title
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Real-time Compression Feedback for Patients With In-hospital Cardiac Arrest: A Multi-Center Randomized Controlled Clinical Trial

Conditions
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Cardiopulmonary Arrest, Cardiopulmonary Resuscitation

Intervention / Treatment
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* Device: Audiovisual compression feedback
* Other: Standard Manual Chest Compression


Participation Criteria
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Eligibility Criteria
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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 ordo not resuscitate (DNR) anddo not intubate (DNI), were excluded from study participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Audiovisual compression feedback<br>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<br>* 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.<br>* Other names: Cardio First Angel™;|
| Active Comparator: Standard chest compression<br>Cardiopulmonary resuscitation according to international guidelines with standard manual chest compression | Other: Standard Manual Chest Compression<br>* Cardiopulmonary resuscitation according to published international guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Return of Spontaneous Circulation | Return of spontaneous circulation | 30 minutes after completion of cardiopulmonary resuscitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to ICU discharge | Survival to first or only ICU discharge | through ICU discharge, usually 15-35 days | 
| Survival to Hospital Discharge | Survival to Hospital Discharge | through study completion, usually 30-45 days | 
| Fractures | Number of rib or sternum fractures | through study completion, usually less than 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPR, Cardio first angle, Cardiopulmonary Arrest, Clinical trial