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NCT05905536Completed

Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor

Source: ClinicalTrials.gov · Last updated 12 Aug 2025

Brief summary (registry, in English)

The purpose of this study is to validate cardiac output and stroke volume derived from Vitalstream against Gold Standard measurements obtained using thermodilution. The Vitalstream device is a continuous noninvasive physiological monitor (Caretaker Medical LLC, Charlottesville, Virginia, further referred to as "CTM") provides heart rate, continuous noninvasive blood pressure (BP), respiratory rate, stroke volume and cardiac output.

Status (registry)
Completed
Study type
Interventional
Enrollment
58 (actual)
First submitted
7 Jun 2023
Start date
15 Aug 2023
Primary completion date
30 Jul 2024
Lead sponsor
Wake Forest University Health Sciences
Diseases
Stroke
NCT number
NCT05905536

What you commit to

  • Study type: Interventional
  • Participants enrolled: 58
  • From 15 Aug 2023 to the primary completion date, 30 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients without an appropriately positioned or functioning (PAC) pulmonary artery catheter admitted to the cardiac surgery ICU after surgery. Patients on left ventricular assist device (LVAD) support

Who the study is looking for

  • Adult post-cardiac surgery needing cardiopulmonary bypass and use of the pulmonary artery catheter (PAC) as standard of care, (s/p coronary artery bypass graft (CABG), valve, heart transplant, major aortic \& other vascular surgery, and a combination of CABG and valve procedures)
  • patients (age \> 18) admitted to the Intensive Care Unit (ICU) with a pulmonary artery catheter (continuous or intermittent thermodilution cardiac output) and an arterial catheter for Blood Pressure (BP) monitoring (standard of care)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Atrium Health Wake Forest Baptist
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.