Effect of the Cardio First Angle Device on CPR Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study of the Effect of Cardio First Angel (CFA) Device on CPR Outcomes:

Conditions
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Cardiopulmonary Arrest

Intervention / Treatment
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* Device: Compression with Feedback
* Other: Standard 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: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compression with Feedback<br>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<br>* 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.<br>* Other names: Cardio First Angel™;|
| Active Comparator: Standard chest compression<br>CPR performed according to established international standards with standard manual chest compression | Other: Standard chest compression<br>* CPR in accordance with published international guidelines using standard manual chest compression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Return of Spontaneous Circulation | ROSC lasting > 30 minutes | through resuscitation completion, an average of 30 to 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nurse Satisfaction Score | Nurse satisfaction with resuscitation event using a validated tool | upon resuscitation completion, an average of 30 to 60 minutes | 
| CPR Duration | Duration of CPR event | through resuscitation completion, an average of 30 to 60 minutes | 
| New post-resuscitation Sternum or Rib Fractures | New sternum or Rib Fractures diagnosed post-resuscitation using X-ray, CT scan, or by Autopsy | through resuscitation completion, an average of 30 to 60 minutes | 
| CPR Evaluation Score | CPR evaluation score assess quality of CPR including chest compression sing a validated tool | upon resuscitation completion, an average of 30 to 60 minutes | 
| CPR Guideline Observation Score | Assesses guideline adherence | upon resuscitation completion, an average of 30 to 60 minutes | 

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