NCT03629535

Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the present investigation is to determine the accuracy of a non-invasive non-oscillometric blood pressure wristband device when compared to invasive intra-arterial blood pressure monitors. In an intensive care unit patients who already have an intra-arterial blood pressure monitor in place, this wristband device will be applied and blood pressure readings compared for approximately 15 minutes. Blood pressure readings will be gathered and compared.

Conditions

• Hypotension
• Hypertension

Interventions

Type	Name	Description
DEVICE	Non-invasive non-oscillometric blood pressure wristband device	The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet.
DEVICE	Invasive intra-arterial blood pressure monitors.	Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-09-10
• Completion: 2019-09-10
• First posted: 2018-08-14
• Last updated: 2021-02-02
• Results posted: 2021-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study