Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status

NCT02907931 | Completed

• 1 other identifier: 1608018234
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; Sepsis

Keywords

hemodynamics; ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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.

  over the course of 1-2 hours during which subjects will undergo incremental changes in lower body negative pressure

Study Arms (1)

Subjects

EXPERIMENTAL

Lower Body Negative Pressure

Other: Point of Care Ultrasound

Interventions

Point of Care Ultrasound OTHER

Subjects

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Generally healthy
• Able to provide informed consent
• Over 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

John B. Pierce Laboratory

New Haven, Connecticut, 06519, United States

Location

Related Publications (18)

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  PMID: 17508199 BACKGROUND

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  PMID: 17508202 BACKGROUND

• Stevens PM, Lamb LE. Effects of lower body negative pressure on the cardiovascular system. Am J Cardiol. 1965 Oct;16(4):506-15. doi: 10.1016/0002-9149(65)90027-5. No abstract available.

  PMID: 5319567 BACKGROUND

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• Moore CL, Rose GA, Tayal VS, Sullivan DM, Arrowood JA, Kline JA. Determination of left ventricular function by emergency physician echocardiography of hypotensive patients. Acad Emerg Med. 2002 Mar;9(3):186-93. doi: 10.1111/j.1553-2712.2002.tb00242.x.

  PMID: 11874773 BACKGROUND

• Moore CL, Tham ET, Samuels KJ, McNamara RL, Galante NJ, Stachenfeld N, Shelley K, Dziura J, Silverman DG. Tissue Doppler of early mitral filling correlates with simulated volume loss in healthy subjects. Acad Emerg Med. 2010 Nov;17(11):1162-8. doi: 10.1111/j.1553-2712.2010.00906.x.

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  PMID: 25834666 BACKGROUND

• Mackenzie DC, Khan NA, Blehar D, Glazier S, Chang Y, Stowell CP, Noble VE, Liteplo AS. Carotid Flow Time Changes With Volume Status in Acute Blood Loss. Ann Emerg Med. 2015 Sep;66(3):277-282.e1. doi: 10.1016/j.annemergmed.2015.04.014. Epub 2015 May 21.

  PMID: 26003002 BACKGROUND

• Bathala L, Mehndiratta MM, Sharma VK. Transcranial doppler: Technique and common findings (Part 1). Ann Indian Acad Neurol. 2013 Apr;16(2):174-9. doi: 10.4103/0972-2327.112460.

  PMID: 23956559 BACKGROUND

• Thomas KN, Lewis NC, Hill BG, Ainslie PN. Technical recommendations for the use of carotid duplex ultrasound for the assessment of extracranial blood flow. Am J Physiol Regul Integr Comp Physiol. 2015 Oct;309(7):R707-20. doi: 10.1152/ajpregu.00211.2015. Epub 2015 Jul 8.

  PMID: 26157060 BACKGROUND

MeSH Terms

Conditions

Hypotension; Sepsis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jill C Crosby, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: January 1, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (1)