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Clinical Trials/NCT04526249
NCT04526249
Completed
Not Applicable

Evaluation of Efficacy of the Prototype RPC (Rapid Pulse Confirmation) Device in Detecting Return of Pulsatile Flow in Patients Preparing to Separate From CPB (Cardiopulmonary Bypass)

Michael Kyle Ritchie1 site in 1 country10 target enrollmentOctober 17, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Circulatory Failure
Sponsor
Michael Kyle Ritchie
Enrollment
10
Locations
1
Primary Endpoint
detection of return of spontaneous circulation by experimental device vs. indwelling arterial catheter
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Effective chest compressions are essential to survival in an arrest patient receiving CPR (cardiopulmonary resuscitation). A challenge in providing effective chest compressions is frequent interruption of compressions. A major cause of a recurrent interruption of chest compressions is pulse checks. Pulse checks are difficult to quickly and accurately perform in the AHA recommended time interval of under 10 seconds for reasons ranging from inexperience to body habitus. Unnecessarily long pulse checks often delay reinitiating chest compressions leading to a fall in perfusion pressure to the coronary arteries lowering the chances of return of spontaneous circulation (ROSC). To potentially solve the issues of evaluating the chest compression effectiveness and minimize the time interval of pulse checks, the authors have constructed a novel device that can be rapidly applied to an arresting patient and evaluate the current state of the circulatory system. The device is called the Rapid Pulse Confirmation (RPC) device. It is designed to applied over a major artery (radial, ulnar, brachial, carotid, and femoral) and detect Doppler shift of red blood cells to gauge red blood cell velocity and rate of pulsation. Feasibility testing on the device was carried out using patients requiring cardiopulmonary bypass. Arrest and return of spontaneous circulation during cardiopulmonary bypass is predictable and provided an ideal environment to test the initial performance of a device meant to detect return of spontaneous circulation. The primary working hypothesis was that there would be no significant difference in time of detection of ROSC between the arterial line catheter and the RPC device at the end of cardiopulmonary bypass. The secondary hypothesis was that there would be no difference in pulse rate reading between the arterial line catheter and the RPC device.

Registry
clinicaltrials.gov
Start Date
October 17, 2017
End Date
January 20, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Michael Kyle Ritchie
Responsible Party
Sponsor Investigator
Principal Investigator

Michael Kyle Ritchie

Primary investigator and Inventor

West Virginia University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

detection of return of spontaneous circulation by experimental device vs. indwelling arterial catheter

Time Frame: less than 5 minutes

Timed in seconds

Study Sites (1)

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