Clinical trial NCT02394977: Effect of the Cardio First Angle Device on CPR Outcomes
Official title: Pilot Study of the Effect of Cardio First Angel (CFA) Device on CPR Outcomes:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Arrest
Keywords: CPR
Cardio first angle
Clinical trial
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
name: West Virginia University
First posted: 2015-03-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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: through resuscitation completion, an average of 30 to 60 minutes
Secondary outcomes:
measure: Nurse Satisfaction Score
timeFrame: upon resuscitation completion, an average of 30 to 60 minutes
measure: CPR Duration
timeFrame: through resuscitation completion, an average of 30 to 60 minutes
measure: New post-resuscitation Sternum or Rib Fractures
timeFrame: through resuscitation completion, an average of 30 to 60 minutes
measure: CPR Evaluation Score
timeFrame: upon resuscitation completion, an average of 30 to 60 minutes
measure: CPR Guideline Observation Score
timeFrame: upon resuscitation completion, an average of 30 to 60 minutes
Other outcomes:
Locations:
Study officials:
affiliation: BMSU
name: Amir vahedian-azimi, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/s13054-016-1296-3.