Effect of the Cardio First Angle Device on CPR Outcomes (CFA)
Primary Purpose
Cardiopulmonary Arrest
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compression with Feedback
Standard chest compression
Sponsored by
About this trial
This is an interventional supportive care trial for Cardiopulmonary Arrest focused on measuring CPR, Cardio first angle, Clinical trial
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Compression with Feedback
Standard chest compression
Arm Description
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.
CPR performed according to established international standards with standard manual chest compression
Outcomes
Primary Outcome Measures
Sustained Return of Spontaneous Circulation
ROSC lasting > 30 minutes
Secondary Outcome Measures
Nurse Satisfaction Score
Nurse satisfaction with resuscitation event using a validated tool
CPR Duration
Duration of CPR event
New post-resuscitation Sternum or Rib Fractures
New sternum or Rib Fractures diagnosed post-resuscitation using X-ray, CT scan, or by Autopsy
CPR Evaluation Score
CPR evaluation score assess quality of CPR including chest compression sing a validated tool
CPR Guideline Observation Score
Assesses guideline adherence
Full Information
NCT ID
NCT02394977
First Posted
March 5, 2015
Last Updated
July 2, 2018
Sponsor
Baqiyatallah Medical Sciences University
Collaborators
Shahid Beheshti University of Medical Sciences, West Virginia University
1. Study Identification
Unique Protocol Identification Number
NCT02394977
Brief Title
Effect of the Cardio First Angle Device on CPR Outcomes
Acronym
CFA
Official Title
Pilot Study of the Effect of Cardio First Angel (CFA) Device on CPR Outcomes:
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baqiyatallah Medical Sciences University
Collaborators
Shahid Beheshti University of Medical Sciences, West Virginia University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Arrest
Keywords
CPR, Cardio first angle, Clinical trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Compression with Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard chest compression
Arm Type
Active Comparator
Arm Description
CPR performed according to established international standards with standard manual chest compression
Intervention Type
Device
Intervention Name(s)
Compression with Feedback
Other Intervention Name(s)
Cardio First Angel™
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard chest compression
Intervention Description
CPR in accordance with published international guidelines using standard manual chest compression.
Primary Outcome Measure Information:
Title
Sustained Return of Spontaneous Circulation
Description
ROSC lasting > 30 minutes
Time Frame
through resuscitation completion, an average of 30 to 60 minutes
Secondary Outcome Measure Information:
Title
Nurse Satisfaction Score
Description
Nurse satisfaction with resuscitation event using a validated tool
Time Frame
upon resuscitation completion, an average of 30 to 60 minutes
Title
CPR Duration
Description
Duration of CPR event
Time Frame
through resuscitation completion, an average of 30 to 60 minutes
Title
New post-resuscitation Sternum or Rib Fractures
Description
New sternum or Rib Fractures diagnosed post-resuscitation using X-ray, CT scan, or by Autopsy
Time Frame
through resuscitation completion, an average of 30 to 60 minutes
Title
CPR Evaluation Score
Description
CPR evaluation score assess quality of CPR including chest compression sing a validated tool
Time Frame
upon resuscitation completion, an average of 30 to 60 minutes
Title
CPR Guideline Observation Score
Description
Assesses guideline adherence
Time Frame
upon resuscitation completion, an average of 30 to 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir vahedian-azimi, PhD, RN
Organizational Affiliation
BMSU
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
27184664
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.
Results Reference
result
Links:
URL
http://ccforum.biomedcentral.com/articles/10.1186/s13054-016-1296-3#Sec11
Description
"Critical Care" site for full text
Learn more about this trial
Effect of the Cardio First Angle Device on CPR Outcomes
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