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NCT05905536 · ClinicalTrials.gov registry record · NA
Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor
A NA study of Cardiac Output, Low and Stroke Volume, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT05905536: Completed NA study of Cardiac Output, Low and Stroke Volume, sponsored by Wake Forest University Health Sciences.
NCT05905536 is a NA study of Cardiac Output, Low and Stroke Volume that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 58 participants, below the 125-participant average among 4 other Cardiac Output, Low trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05905536, a NA study of Cardiac Output, Low and Stroke Volume, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Cardiac output values correlation of cardiac output between the PA catheter as assessed by the CCO and the VitalStream - the amount of blood pumped by the heart minute - Cardiac output is calculated by multiplying stroke volume with heart rate - Cardiac output in humans is generally 5-6 L/min in an at-rest to more than 35 L/min in elite athletes during exercise. HR is determined by signals from the sinoatrial node, which automatically depolarizes at an intrinsic rate of 60 to 100 times each minu
Conditions Studied
Interventions
- DEVICE Vitalstream
Study Locations (1)
North Carolina
- Atrium Health Wake Forest Baptist - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2023-08-15 |
| Est. Completion | 2024-07-30 |
| Phase | NA |
What the finished NCT05905536 record still lists
NCT05905536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 125-participant average among 4 other Cardiac Output, Low trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with Cardiac Output, Low appearing as the primary indexed condition, and to 1 intervention - of which Vitalstream is the first listed.
NCT05905536 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05905536 about?
NCT05905536 is a clinical study titled "Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor". 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 ref...
What is the current status of trial NCT05905536?
This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2023-08-15. Estimated completion is 2024-07-30.
What conditions does trial NCT05905536 study?
This clinical trial studies the following conditions: Cardiac Output, Low, Stroke Volume.
What interventions are being tested in trial NCT05905536?
The interventions under investigation include: Vitalstream (DEVICE).
Who is sponsoring clinical trial NCT05905536?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05905536 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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