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)

NCT04526249 | Completed

• 1 other identifier: 1708690742
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Circulatory Failure; Cardiac Arrest

Keywords

cardio pulmonary resuscitation; pulse detection; chest compressions

Outcome Measures

Primary Outcomes (1)

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

  Timed in seconds

  less than 5 minutes

Interventions

rapid pulse confirmation device DEVICE

device used to detect pulsatile blood blood during and after cardiac arrest

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled isolated open-heart valve or isolated coronary artery bypass graft surgery.

Sponsors & Collaborators

• Michael Kyle Ritchie: lead
• West Virginia Clinical and Translational Science Institute: collaborator

Study Sites (1)

West Virginia University Ruby Memorial Hospital

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Shock; Heart Arrest

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary investigator and Inventor

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: August 25, 2020
• Study Start: October 17, 2017
• Primary Completion: January 20, 2019
• Study Completion: January 20, 2019
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)