Ultrasound Assessment of Changes in the Diameter of the Common Carotid Artery After Increasing the Preload of the Heart

Ultrasound Assessment of Changes in the Diameter of the Common Carotid Artery After Increasing the Preload of the Heart With Passive Leg Raise and Intravenous Fluid Infusion

Passive leg raise (PLR) and fluid challenge are useful tools in assessing the fluid responsiveness. However, they require continuous monitoring of cardiac output, which is usually an invasive technique and in some cases not always available. Vascular ultrasound can be an alternative to cardiac output monitoring in a fluid status evaluation. The common carotid artery (CCA) is an easily accessible vessel. It has recently been noted that the diameter of this artery changes after an intravenous fluid bolus. It is possible that the change in the diameter of the common carotid artery during passive leg raise and fluid challenge can be a predictor of fluid responsiveness.

Study Overview

• Status: Withdrawn
• Conditions: Critical Illness; Fluid Responsiveness
• Intervention / Treatment: Diagnostic test: fluid responsiveness assessment

• Study Type: Observational

Contacts and Locations

Study Locations

• Poland
  • Opolskie
    • Opole, Opolskie, Poland, 45-372
      • Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Mechanically ventilated patients admitted to critical care unit.

Description

Inclusion Criteria:

• mechanically ventilated patients with circulatory failure, who are monitored with PiCCO and need fluid responsiveness assessment

Exclusion Criteria:

• contraindication for the volume administration (hydrostatic pulmonary edema or other evidence of fluid overload)
• contraindication for PLR test (e.g. after trauma)
• lack of possibility to examine the carotid arteries
• bilateral carotid surgery in the past
• bilateral anatomical defects of the carotid arteries
• unstable cardiac rhythm (e.g. atrial fibrillation)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Acute circulatory failure; Mechanically ventilated patients with acute circulatory failure, monitored with PiCCO method, who need fluid responsiveness assessment.

Diagnostic test: fluid responsiveness assessment; During the procedure, the investigator will be imaging one of the carotid arteries with ultrasound. In expiratory phase, four sets of three video loops will be recorded: before and after PLR and then before and after fluid challenge. There also will be noted hemodynamic parameters measured with PiCCO monitor. The fluid challenge is defined as administration of 500ml of crystalloid in less than 10 minutes. Later, another investigator, who will be blinded to other data, will measure the maximal and minimal diameter of CCA in each loop. The measurements will be averaged and eventually two values (maximal an minimal) from each set will be obtained.; Other Names: fluid challenge; passive leg raise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the diameter of the common carotid artery	The diameter will be measured with ultrasound	1 minute after PLR test and 1 minute after fluid challenge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation the value of changes in the diameter of CCA as the predictor of fluid responsiveness.	The changes in the diameter of CCA will be compared with the changes in cardiac output measured with PiCCO method.	1 minute after PLR test and 1 minute after fluid challenge

Collaborators and Investigators

• Sponsor: Uniwersytecki Szpital Kliniczny w Opolu

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: January 21, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Fluid Challenge; Common carotid artery; Passive Leg Raise
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: CCA_USG_PLR_USK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No