Compression Feedback for Patients With In-hospital Cardiac Arrest

Not Applicable

Completed

• Conditions: Cardiopulmonary Resuscitation; Cardiopulmonary Arrest
• Interventions: Other: Standard Manual Chest Compression; Device: Audiovisual compression feedback

• Registration Number: NCT02845011
• Lead Sponsor: Baqiyatallah Medical Sciences University

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2015-09-15
• Study Completion: 2015-12-30
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-26
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard chest compression	Standard Manual Chest Compression	Cardiopulmonary resuscitation according to international guidelines with standard manual chest compression
Audiovisual compression feedback	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.

Primary Outcome Measures

Name	Time	Method
Sustained Return of Spontaneous Circulation	30 minutes after completion of cardiopulmonary resuscitation	Return of spontaneous circulation

Secondary Outcome Measures

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