MedTrace Logo

Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor

NCT05905536 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-08-12

No results posted yet for this study

Summary

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.

Conditions

  • Cardiac Output, Low
  • Stroke Volume

Interventions

DEVICE

Vitalstream

The device will be placed on the subject and monitoring started in the holding room on the morning of surgery. Monitoring will continue postoperatively until the pulmonary artery catheter (PAC) is removed (Standard of Care) or discharged, or at study team discretion. At Intensive Care Unit (ICU) admittance and again 3 hours later a straight leg raise will be done to monitor for changes in hemodynamics.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Ashish Khanna, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2024-07-30
Completion
2024-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05905536 on ClinicalTrials.gov