Effect of the Cardio First Angle Device on CPR Outcomes

Not Applicable

Completed

• Conditions: Cardiopulmonary Arrest
• Interventions: Device: Compression with Feedback; Other: Standard chest compression

• Registration Number: NCT02394977
• Lead Sponsor: Baqiyatallah Medical Sciences University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-20
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Compression with Feedback	Compression with Feedback	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.
Standard chest compression	Standard chest compression	CPR performed according to established international standards with standard manual chest compression

Primary Outcome Measures

Name	Time	Method
Sustained Return of Spontaneous Circulation	through resuscitation completion, an average of 30 to 60 minutes	ROSC lasting \> 30 minutes

Secondary Outcome Measures

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