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Effect of the Cardio First Angle Device on CPR Outcomes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02394977
Acronym
CFA
Enrollment
80
Registered
2015-03-20
Start date
2014-01-31
Completion date
2014-12-31
Last updated
2018-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Arrest

Keywords

CPR, Cardio first angle, Clinical trial

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.

Interventions

DEVICECompression 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.

OTHERStandard chest compression

CPR in accordance with published international guidelines using standard manual chest compression.

Sponsors

Shahid Beheshti University of Medical Sciences
CollaboratorOTHER
West Virginia University
CollaboratorOTHER
Baqiyatallah Medical Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sustained Return of Spontaneous Circulationthrough resuscitation completion, an average of 30 to 60 minutesROSC lasting \> 30 minutes

Secondary

MeasureTime frameDescription
Nurse Satisfaction Scoreupon resuscitation completion, an average of 30 to 60 minutesNurse satisfaction with resuscitation event using a validated tool
CPR Durationthrough resuscitation completion, an average of 30 to 60 minutesDuration of CPR event
New post-resuscitation Sternum or Rib Fracturesthrough resuscitation completion, an average of 30 to 60 minutesNew sternum or Rib Fractures diagnosed post-resuscitation using X-ray, CT scan, or by Autopsy
CPR Evaluation Scoreupon resuscitation completion, an average of 30 to 60 minutesCPR evaluation score assess quality of CPR including chest compression sing a validated tool
CPR Guideline Observation Scoreupon resuscitation completion, an average of 30 to 60 minutesAssesses guideline adherence

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026