No Specific Conditions Are Being Examined
Conditions
Keywords
Blood pressure comparison
Brief summary
The goal of the proposed study is to test the capability of the Vitalstream monitor's continuous blood pressure tracking ability against Gold Standard.
Detailed description
The goal of the proposed study is to test the capability of the Vitalstream monitor's continuous blood pressure tracking ability against Gold Standard, either an arterial line or an upper arm cuff, to assess the capabilities and limitations of the technology. Specifically, the objective is to demonstrate the Vitalstream's ability to adhere to the limits prescribed by ANSI/AAMI/ISO 81060-2:2019 as closely as possible.
Interventions
DEVICEVitalstream
Non-invasive BP monitoring. No intervention
Sponsors
CareTaker Medical LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients 18 years of age or older having the following surgery or procedures Electrophysiology Lab patients undergoing ablation Cardiac Catheterization Lab patients undergoing heart catheterization Cardiac Surgery patients including CABG and/or cardiac valve repair/replacement Abdominal Surgery patients including hepatectomy, pancreatectomy, and gastrectomy
Exclusion criteria
Patients less than 18 years of age Patients with any pre-existing finger or hand injury which will preclude the placement of the Caretaker finger blood pressure cuff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BP Reading Agreement | 30 minutes to 24 hours | — |
| BP reading agreement according to ISO 81060 standard | 30 minutes to 24 hours | BP reading agreement according to ISO 81060 standard |
Outcome results
None listed