MedPath

RapidShock Post-Approval Study

Not Applicable
Completed
Conditions
Cardiac Arrest
Interventions
Device: RapidShock
Registration Number
NCT04014842
Lead Sponsor
Zoll Medical Corporation
Brief Summary

Compare the performance of the Reconfirmation Analysis Mode algorithm to the performance goals recommended by the American Heart Association.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2756
Inclusion Criteria
  • 8 years of age or older and weight ≥ 55 lbs (25 kgs)
  • Out-of-hospital cardiac arrest (OOHCA)
  • Non-traumatic cardiac arrest
Exclusion Criteria
  • Weight less than 55 lbs (25 kgs)
  • Do not attempt resuscitation (DNAR) orders

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
RapidShockRapidShockPatients receiving xseries device with rapid shock enabled
Primary Outcome Measures
NameTimeMethod
Algorithm accuracyaverage of up to 1 hour after device placement

Accuracy of the algorithm compared to manual annotation for each rhythm

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

East Baton Rouge Parish EMS

🇺🇸

Baton Rouge, Louisiana, United States

San Antonio Fire

🇺🇸

San Antonio, Texas, United States

Colorado Springs Fire Department

🇺🇸

Colorado Springs, Colorado, United States

M Health Fairview EMS

🇺🇸

Saint Paul, Minnesota, United States

Ventura County Fire Department

🇺🇸

Camarillo, California, United States

Detroit Fire Department

🇺🇸

Detroit, Michigan, United States

Fort Worth Fire Department

🇺🇸

Fort Worth, Texas, United States

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