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Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor

Primary Purpose

Cardiac Output, Low, Stroke Volume

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitalstream
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Output, Low focused on measuring cardiac output, cardiac surgery, pulmonary artery catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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

Sites / Locations

  • Atrium Health Wake Forest BaptistRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitalstream

Arm Description

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

Outcomes

Primary Outcome Measures

Cardiac output values
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 minute - Low-output symptoms are caused by the inability of the heart to generate enough cardiac output. This leads to reduced blood flow to the brain and other vital organs
Blood pressure values
correlation of blood pressure continuously being monitored by the Vitalstream and the subjects indwelling arterial line

Secondary Outcome Measures

Full Information

First Posted
June 7, 2023
Last Updated
August 28, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05905536
Brief Title
Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor
Official Title
Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The device is currently undergoing IEC 60601 Medical Safety Standards testing and has already passed all FDA-required emission and discharge testing. The Vitalstream tracks central aortic BP via pulse analysis, specifically Pulse Decomposition Analysis ("PDA"), of the peripheral pulse at a distal site, typically finger. The device uses a low pressure [30-40 mmHg], pump-inflated, finger cuff that pneumatically couples arterial pulsations via a pressure line to a custom-designed piezo-electric pressure sensor for detection and analysis. Physiological data are communicated wirelessly to a tablet-based user interface via Bluetooth. The Vitalstream monitor is most beneficial as it is non-invasive, is a minimal risk device, and for this protocol will not be utilized to make treatment decisions for the study subject.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output, Low, Stroke Volume
Keywords
cardiac output, cardiac surgery, pulmonary artery catheter

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
cardiac patient population through the major part of their continuum of care, with monitoring starting at the start of the subjects holding room pre-operative preparation and continuing through surgery to recovery in the Cardiovascular Intensive Care Unit (CVICU), where monitoring will continue until the pulmonary artery catheter (PAC) is removed
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitalstream
Arm Type
Experimental
Arm Description
Device placed on the subject preoperatively in the holding room and continued postoperatively into the Cardiac Intensive Care Unit (ICU).
Intervention Type
Device
Intervention Name(s)
Vitalstream
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiac output values
Description
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 minute - Low-output symptoms are caused by the inability of the heart to generate enough cardiac output. This leads to reduced blood flow to the brain and other vital organs
Time Frame
hour 24
Title
Blood pressure values
Description
correlation of blood pressure continuously being monitored by the Vitalstream and the subjects indwelling arterial line
Time Frame
hour 24
Other Pre-specified Outcome Measures:
Title
Assessment of fluid responsiveness changes
Description
Assessment of fluid responsiveness using a passive leg raising test (PLR) maneuver, within 1 hour of ICU admission and 3 hours later. We will access fluid challenge using the fluid challenge timer feature on the VitalStream, by doing serial assessments before and after each passive leg raising test. PLR is a simple bedside technique that can be used to assess fluid responsiveness. This maneuver can be used as a pseudo-fluid challenge of an approximately of 150-300 mL by placing patient head down flat and feet up at a 45° angle. Blood from the lower extremities translocate to intrathoracic compartment where the right and left ventricular preload increases and if the patient is responsive increases SV and cardiac output. An increase in SV of more than 10% indicates the patient is preload responsive with the high sensitivity and specificity.
Time Frame
Hours 1 and 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashish Khanna, MD
Phone
513-658-5866
Email
akhanna@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashish Khanna, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashish Khanna, MD
Phone
513-658-5866
Email
akhanna@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Lynnette C Harris, BSN
Phone
336-716-8791
Email
lcharris@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Ashish Khanna, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor

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