Effect of the Cardio First Angle Device on CPR Outcomes

Cardiopulmonary Arrest Clinical Trial

— CFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394977
• Other study ID #: BMSU-390-5-5904
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2014

Study information

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

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• 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
• Heart Arrest

Intervention

Device:
• Compression with Feedback
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.

Other:
• Standard chest compression
CPR in accordance with published international guidelines using standard manual chest compression.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University	Shahid Beheshti University of Medical Sciences, West Virginia University

References & Publications (1)

Vahedian-Azimi A, Hajiesmaeili M, Amirsavadkouhi A, Jamaati H, Izadi M, Madani SJ, Hashemian SM, Miller AC. Effect of the Cardio First Angel™ device on CPR indices: a randomized controlled clinical trial. Crit Care. 2016 May 17;20(1):147. doi: 10.1186/s13 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Return of Spontaneous Circulation	ROSC lasting > 30 minutes	through resuscitation completion, an average of 30 to 60 minutes
Secondary	Nurse Satisfaction Score	Nurse satisfaction with resuscitation event using a validated tool	upon resuscitation completion, an average of 30 to 60 minutes
Secondary	CPR Duration	Duration of CPR event	through resuscitation completion, an average of 30 to 60 minutes
Secondary	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
Secondary	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
Secondary	CPR Guideline Observation Score	Assesses guideline adherence	upon resuscitation completion, an average of 30 to 60 minutes

External Links

•   "Critical Care" site for full text