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

August 17, 2026 updated by: CareTaker Medical LLC

Vitalstream Gold Standard Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cooper Union Hospital patients receiving surgical, EP-Lab or Cath-Lab services

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cooper Union patients
OR, ICU, EP-Lab, Cath-lab patients
Device: Vitalstream
Non-invasive BP monitoring. No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BP Reading Agreement
Time Frame: 30 minutes to 24 hours
30 minutes to 24 hours
BP reading agreement according to ISO 81060 standard
Time Frame: 30 minutes to 24 hours
BP reading agreement according to ISO 81060 standard
30 minutes to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CareTaker Medical LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 24, 2026

Primary Completion (Estimated)

August 24, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

August 17, 2026

First Submitted That Met QC Criteria

August 17, 2026

First Posted (Actual)

August 20, 2026

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Hemo_003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe