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Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status

Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status During Lower Body Negative Pressure Simulation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02907931
Enrollment
29
Registered
2016-09-20
Start date
2016-09-30
Completion date
2020-01-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Sepsis

Keywords

hemodynamics, ultrasonography

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.

Interventions

OTHERPoint of Care Ultrasound

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
changes in carotid blood flow (measured by velocity time integral, VTI) in subjects undergoing simulated hypovolemiaover the course of 1-2 hours during which subjects will undergo incremental changes in lower body negative pressureWe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026