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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)

M

Michael Kyle Ritchie

Status

Completed

Conditions

Circulatory Failure
Cardiac Arrest

Treatments

Device: rapid pulse confirmation device

Study type

Observational

Funder types

Other

Identifiers

NCT04526249
1708690742

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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