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OpenTrials
Completed

NCT Number: NCT04526249

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)

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

West Virginia University Ruby Memorial Hospital

Morgantown, West Virginia, 26506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion: 1.18 or older 2.EF >40% on pre-operative echocardiogram 3.Patient with isolated cardiac valve disease to be repaired during scheduled surgery Exclusion: 1.Redo procedure 2.Emergency procedure 3.Peripheral vascular disease 4.Previous cannulation or harvesting of radial artery 5.Arterial stents in the radial, ulnar, brachial, femoral, or carotid arteries 6.History of peripheral arterial bypass 7.History of carotid artery stenosis 8.Thoracic outlet syndrome 9.Valvular heart disease NOT being repaired day of surgery 10.Heart rhythm other than sinus prior to procedure (occasional PVC's ok) 11.Patient refusal

Treatment and study plan

rapid pulse confirmation device

Device

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

Primary outcomes

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

    Time frame: less than 5 minutes

    Timed in seconds

Sponsors and collaborators

Lead sponsor

Michael Kyle Ritchie

Other

Collaborators

  • West Virginia Clinical and Translational Science Institute

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 25, 2020
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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