Compression Feedback for Patients With In-hospital Cardiac Arrest

Cardiopulmonary Resuscitation Clinical Trial

— CFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845011
• Other study ID #: BMSU CFA Prospective
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 30, 2015

Study information

• Verified date: July 2018
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: December 30, 2015
• Est. primary completion date: September 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Arrest
• Cardiopulmonary Resuscitation
• Heart Arrest

Intervention

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:
• Standard Manual Chest Compression
Cardiopulmonary resuscitation according to published international guidelines.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University	East Carolina University, Shahid Beheshti University, Tehran University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Return of Spontaneous Circulation	Return of spontaneous circulation	30 minutes after completion of cardiopulmonary resuscitation
Secondary	Survival to ICU discharge	Survival to first or only ICU discharge	through ICU discharge, usually 15-35 days
Secondary	Survival to Hospital Discharge	Survival to Hospital Discharge	through study completion, usually 30-45 days
Secondary	Fractures	Number of rib or sternum fractures	through study completion, usually less than 60 days