Comparison Study for Hemodynamic Parameters Generated by Vitalstream Relative to Appropriate Gold Standard References in Different Clinical Settings, (OR, EP Lab Etc.).

N/ANot Yet RecruitingNCT07775469

CareTaker Medical LLC60 enrolled

Overview

The goal of the proposed study is to test the capability of the Vitalstream monitor's continuous blood pressure tracking ability against Gold Standard.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

No Specific Conditions Are Being Examined

Interventions

VitalstreamDEVICE

Non-invasive BP monitoring. No intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

BP Reading Agreement

Time frame: 30 minutes to 24 hours

BP reading agreement according to ISO 81060 standard

Time frame: 30 minutes to 24 hours

Data from ClinicalTrials.gov

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