Cardiopulmonary Arrest, Cardiopulmonary Resuscitation
Conditions
Keywords
Cardio first angle, CPR, Cardiopulmonary Arrest, Clinical trial
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.
Interventions
DEVICEAudiovisual 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.
OTHERStandard Manual Chest Compression
Cardiopulmonary resuscitation according to published international guidelines.
Sponsors
Shahid Beheshti University
Tehran University of Medical Sciences
East Carolina University
Baqiyatallah Medical Sciences University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The clinical provider was not involved in the study. S(he) was not blind during the resuscitation as they could see device, and it was not considered ethical to employ a sham device.
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
| Measure | Time frame | Description |
|---|---|---|
| Sustained Return of Spontaneous Circulation | 30 minutes after completion of cardiopulmonary resuscitation | Return of spontaneous circulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Fractures | through study completion, usually less than 60 days | Number of rib or sternum fractures |
Outcome results
None listed