None listed
Conditions
Brief summary
The study aims to collect blood pressure readings via conventional cuffed BP machines and concurrently collect blood pressure readings cuff-lessly via a novel device called Ora Connect that has been developed by the Zaplutus IQ company. Tilt Table Testing and an alternative Posture and Exertion procedure will be used as these procedures commonly induce a change in blood pressure for the participant. By collecting comparative blood pressure readings, the intent is demonstrate that cuff-less blood pressure is as accurate as cuffed blood pressure.
Interventions
Participants are recruited from two groups: Group A: The participant is scheduled to undergo a clinically indicated tilt table test (TTT) performed by a Cardiologist: or Group B: The participant has been recruited to undergo a Posture and Exertion Procedure. Group A: Tilt Table Test Participants will undergo a standard Tilt Table Test of approximately 60 minutes duration beginning with a pre-test supine baseline. Standard tilt table test monitoring equipment consisting of heart rate (HR) and rhythm (ECG) monitoring, and a sphygmomanometer BP cuff on the patient’s right arm will be applied. An Ora Connect device will be applied to the patient’s chest and continuous HR, ECG, and cuff-less blood pressure (BP) recordings will commence. A standard automated oscillometric cuffed NIBP machine will be applied to the patients left arm. The participant will then undergo passive 70° head-up tilt for 20 minutes, with continuous HR and ECG, and BP measurement every two minutes. If insufficient cardiovascular response occurs during the TTT, optional sublingual nitroglycerin is usually administered, followed by continued head-up tilt and monitoring. The session concludes with a recovery period in the supine position, during which vitals are continuously recorded. Termination criteria include syncope/presyncope, severe hypotension, prolonged arrhythmia, participant request, or protocol completion without symptoms. The Ora Connect device will concurrently capture continuous HR, ECG and cuff-less BP data, along with automated oscillometric cuffed NIBP every two minutes, and posture throughout the procedure. Group B: Posture and Exertion Procedure Participants undergoing this procedure will have monitoring applied as per the TTT, with the addition of a TGA approved pulse oximeter (Sp02) to one of their finger’s. Participants complete baseline posture stages (sitting, standing, supine), with continuous device recording and cuffed BP every two minutes. This is followed by a 20–40 minute exertional component involving either handgrip (squeeze of spring grips in both hands) or exercise bike exertion. Cuffed BP and device recordings are maintained throughout exercise and a five-minute recovery period. Ora Connect Device: The device under investigation is a small wireless chest worn device that measures all vital signs concurrently and in real time within the single device.
Sponsors
Study design
Eligibility
Inclusion criteria
Participants of both Group A and Group B will equally be able to enrolled : • Participants who are healthy and not known to have hypertension • Participants who are known to have hypertension, who may or may not be on medication • Participants who consent to the study, and do not meet any exclusion criteria
Exclusion criteria
For both Group A and Group B: • Pre-existing skin sensitivities or allergies to medical adhesives • Hypertension with a systolic greater than 180mmHg or diastolic greater than 100mmHg • Hypotension with a systolic less than 90mmHg • Resting tachycardia of greater than 100 beats per minute • Pregnancy