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Physiological Monitor

Perioperative Monitoring with Vitalstream for Low Cardiac Output

N/A

Recruiting

Led By Ashish Khanna, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hour 24

Awards & highlights

Study Summary

This trial tests the accuracy of a device that measures heart rate, BP, resp. rate, stroke volume & cardiac output, compared to a Gold Standard.

Who is the study for?

This trial is for adults over 18 in the ICU after cardiac surgery who need a pulmonary artery catheter and arterial BP monitoring. It's not for patients with left ventricular assist devices or those without a properly placed or working pulmonary artery catheter post-surgery.Check my eligibility

What is being tested?

The study tests Vitalstream, a noninvasive monitor that measures heart rate, blood pressure, respiratory rate, stroke volume, and cardiac output against standard thermodilution methods used in intensive care.See study design

What are the potential side effects?

Since Vitalstream is a monitoring device rather than a medication or invasive procedure, it's expected to have minimal side effects related to its use on the skin or possible discomfort from wearing the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18, in the ICU, and have catheters for heart and BP monitoring.

Select...

I had heart surgery requiring a heart-lung machine and a special heart monitoring catheter.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hour 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hour 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and hour 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood pressure values

Cardiac output values

Other outcome measures

Assessment of fluid responsiveness changes

Trial Design

1Treatment groups

Experimental Treatment

Group I: VitalstreamExperimental Treatment1 Intervention

Device placed on the subject preoperatively in the holding room and continued postoperatively into the Cardiac Intensive Care Unit (ICU).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,684 Total Patients Enrolled

Ashish Khanna, MDPrincipal InvestigatorWake Forest University Health Sciences

2 Previous Clinical Trials

1,050 Total Patients Enrolled

Media Library

Vitalstream (Physiological Monitor) Clinical Trial Eligibility Overview. Trial Name: NCT05905536 — N/A

Stroke Volume Research Study Groups: Vitalstream

Stroke Volume Clinical Trial 2023: Vitalstream Highlights & Side Effects. Trial Name: NCT05905536 — N/A

Vitalstream (Physiological Monitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05905536 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still possible to sign up for this research endeavor?

"Unfortunatley, the clinicaltrials.gov website states that this trial is not actively seeking patients at present. It was first posted on June 1st 2023 and last updated on the 7th of the same month. Fortunately, there are 6 other studies currently recruiting participants to join them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor

2023. "Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05905536.