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)

Completed

• Conditions: Cardiac Arrest; Circulatory Failure

• Registration Number: NCT04526249
• Lead Sponsor: Michael Kyle Ritchie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-17
• Primary Completion: 2019-01-20
• Study Completion: 2019-01-20
• Study First Submitted: 2019-06-06
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-20
• Last Update Submitted: 2020-08-20
• Study First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
detection of return of spontaneous circulation by experimental device vs. indwelling arterial catheter	less than 5 minutes	Timed in seconds

Trial Locations

Locations (1)

West Virginia University Ruby Memorial Hospital; 🇺🇸 Morgantown, West Virginia, United States