Clinical trial NCT02845011: Compression Feedback for Patients With In-hospital Cardiac Arrest
Official title: Real-time Compression Feedback for Patients With In-hospital Cardiac Arrest: A Multi-Center Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Arrest
Cardiopulmonary Resuscitation
Keywords: Cardio first angle
CPR
Cardiopulmonary Arrest
Clinical trial
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University
name: Tehran University of Medical Sciences
name: East Carolina University
First posted: 2016-07-26
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sustained Return of Spontaneous Circulation
timeFrame: 30 minutes after completion of cardiopulmonary resuscitation
Secondary outcomes:
measure: Survival to ICU discharge
timeFrame: through ICU discharge, usually 15-35 days
measure: Survival to Hospital Discharge
timeFrame: through study completion, usually 30-45 days
measure: Fractures
timeFrame: through study completion, usually less than 60 days
Other outcomes:
Locations:
Study officials:
affiliation: Baqiyatallah Universiy of Medical Sciences
name: Amir Vahedian-azimi, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goharani R, Vahedian-Azimi A, Farzanegan B, Bashar FR, Hajiesmaeili M, Shojaei S, Madani SJ, Gohari-Moghaddam K, Hatamian S, Mosavinasab SMM, Khoshfetrat M, Khabiri Khatir MA, Miller AC; MORZAK Collaborative. Real-time compression feedback for patients with in-hospital cardiac arrest: a multi-center randomized controlled clinical trial. J Intensive Care. 2019 Jan 22;7:5. doi: 10.1186/s40560-019-0357-5. eCollection 2019.