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)

Cardiac Arrest Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04526249
• Other study ID #: 1708690742
• Status: Completed
• Start date: October 17, 2017
• Est. completion date: January 20, 2019

Study information

• Verified date: August 2020
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 20, 2019
• Est. primary completion date: January 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Circulatory Failure
• Shock

Intervention

Device:
• rapid pulse confirmation device
device used to detect pulsatile blood blood during and after cardiac arrest

Locations

Country	Name	City	State
United States	West Virginia University Ruby Memorial Hospital	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Michael Kyle Ritchie	West Virginia Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of return of spontaneous circulation by experimental device vs. indwelling arterial catheter	Timed in seconds	less than 5 minutes