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Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status

Primary Purpose

Hypotension, Sepsis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point of Care Ultrasound
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypotension focused on measuring hemodynamics, ultrasonography

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  1. Generally healthy
  2. Able to provide informed consent
  3. Over 18 years of age

Exclusion criteria:

  1. Non-English speaking or decisionaly impaired
  2. Significant medical illness (as determined by the study physician, JC)
  3. Taking vasoactive medications
  4. Older than 60 years of age
  5. Inability to lie flat for prolonged period
  6. Severe claustrophobia
  7. Pregnant

Sites / Locations

  • John B. Pierce Laboratory

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects

Arm Description

Lower Body Negative Pressure

Outcomes

Primary Outcome Measures

changes in carotid blood flow (measured by velocity time integral, VTI) in subjects undergoing simulated hypovolemia
We will attach adhesive electrodes to your chest which allow us to monitor and record your vital signs. You will lie on your back on a table with the lower half of your body enclosed in a box. The box has a vacuum that creates suction and causes blood to pool in your legs and feet. Next you will do a Lower Body Negative Pressure test. For this test, you will lie with your lower body in the box while we apply increasing levels of suction, over 4 different intervals, lasting 2 minutes each. We will repeat the suction for longer times at each interval and obtain ultrasound images of blood vessels in your head and neck. Each interval may last up to 20 minutes for a total of up to 80 minutes time spent in the chamber.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2016
Last Updated
January 9, 2020
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02907931
Brief Title
Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status
Official Title
Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status During Lower Body Negative Pressure Simulation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Ultrasound represents an attractive non-invasive method to assess hemodynamic status. Understanding dynamic changes in hemodynamics in situations such as hypovolemia, sepsis, and cardiogenic shock can potentially help improve patient care. However, the inter-rater reliability and accuracy of how various ultrasound measurements reflect dynamic changes in physiology remains incompletely understood. Overall our aims are to investigate the use of ultrasound in a controlled setting, specifically using lower body negative pressure (LBNP), which can simulate hypovolemia at varied levels in human volunteers. Aim 1: To determine the change in carotid blood flow (measured by velocity time integral, VTI) in subjects undergoing simulated hypovolemia at LBNP levels that precede vital sign changes. Hypothesis: Carotid VTI will demonstrate significant changes that precede vital sign changes in simulated hypovolemia. Aim 2: To compare transcranial color Doppler indices of cerebral blood flow with carotid blood flow, as assessed by VTI of the common carotid artery. Hypothesis: Changes in transcranial color Doppler indices of cerebral blood flow will be mirrored by changes in carotid blood flow, indicating carotid VTI is an adequate surrogate for measuring cerebral blood flow in variable states of central hypovolemia. However, if cerebral blood flow remains more constant than carotid blood flow throughout varying levels of hypovolemia, our assumption is that cerebral autoregulation alters the relationship between carotid and cerebral blood flow. The more complex procedure of Transcranial Doppler ultrasound (TCD) must be performed to obtain valid assessments of cerebral blood flow.
Detailed Description
Study Design: This is a prospective laboratory study using human volunteers. Study Setting and Subjects: The study will take place in The John B. Pierce Laboratory where volunteers will be subjected to lower body negative pressure using the on-site LBNP chamber. Protocol: Study subjects will be instructed to refrain from caffeine, alcohol, or cigarettes within 12 hours of the protocol, but will otherwise be allowed their routine oral intake prior to enrollment. The chamber is constructed of a sealed wood and acrylic box that is connected to a vacuum. Subjects will be placed into the chamber, which is sealed to the level of their pelvis by a neoprene skirt. Chamber pressure is transduced to an electronic digital manometer. The pressure in the chamber will reduced rapidly and held for 15-minute intervals at -5, -10, -15, and -20 mm Hg. If the subject becomes lightheaded, nauseated, or does not tolerate the test run in any way; negative pressure will be stopped. Subjects will be monitored with continuous electrocardiogram monitoring, a standard automated blood pressure cuff, and a noninvasive beat-to-beat hemodynamic monitor (Finometer, Finapres Medical Systems, Amsterdam, The Netherlands). All carotid ultrasound measurements will be performed by specifically trained emergency physicians, using a Philips ultrasound machine (Philips Medical Systems, Andover, MA) equipped with phased and linear array probes programmed with Doppler capability. For transcranial Doppler imaging, we will use a 5- to 1-MHz sector array transducer and an Iu-22 ultrasound system (Philips Healthcare, Best, the Netherlands). Duplex sonography will be performed at the lower end of the frequency range (1-2 MHz) for better sound wave penetration of selected bone windows. For both the common carotid artery and transcranial portion of this study, we will obtain spectral Doppler waveform tracings and record measurements of corresponding vessel diameters. We will use data generated from software analysis of these spectral tracings to calculate hemodynamic parameters of interest to our study. Calculations are based on Bernoulli's principles of fluid dynamics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Sepsis
Keywords
hemodynamics, ultrasonography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects
Arm Type
Experimental
Arm Description
Lower Body Negative Pressure
Intervention Type
Other
Intervention Name(s)
Point of Care Ultrasound
Primary Outcome Measure Information:
Title
changes in carotid blood flow (measured by velocity time integral, VTI) in subjects undergoing simulated hypovolemia
Description
We will attach adhesive electrodes to your chest which allow us to monitor and record your vital signs. You will lie on your back on a table with the lower half of your body enclosed in a box. The box has a vacuum that creates suction and causes blood to pool in your legs and feet. Next you will do a Lower Body Negative Pressure test. For this test, you will lie with your lower body in the box while we apply increasing levels of suction, over 4 different intervals, lasting 2 minutes each. We will repeat the suction for longer times at each interval and obtain ultrasound images of blood vessels in your head and neck. Each interval may last up to 20 minutes for a total of up to 80 minutes time spent in the chamber.
Time Frame
over the course of 1-2 hours during which subjects will undergo incremental changes in lower body negative pressure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Generally healthy Able to provide informed consent Over 18 years of age Exclusion criteria: Non-English speaking or decisionaly impaired Significant medical illness (as determined by the study physician, JC) Taking vasoactive medications Older than 60 years of age Inability to lie flat for prolonged period Severe claustrophobia Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill C Crosby, MD, MHS
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
John B. Pierce Laboratory
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status

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