Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status

Not Applicable

Completed

• Conditions: Sepsis; Hypotension
• Interventions: Other: Point of Care Ultrasound

• Registration Number: NCT02907931
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-14
• Study First Posted: 2016-09-20
• Primary Completion: 2018-07
• Status Verified: 2020-01
• Study Completion: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects	Point of Care Ultrasound	Lower Body Negative Pressure

Primary Outcome Measures

Name	Time	Method
changes in carotid blood flow (measured by velocity time integral, VTI) in subjects undergoing simulated hypovolemia	over the course of 1-2 hours during which subjects will undergo incremental changes in lower body negative pressure	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.

Trial Locations

Locations (1)

John B. Pierce Laboratory; 🇺🇸 New Haven, Connecticut, United States