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

NCT03412422 | Withdrawn

• 1 other identifier: CCA_USG_PLR_USK
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Fluid Responsiveness

Keywords

Passive Leg Raise; Fluid Challenge; Common carotid artery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation the value of changes in the diameter of CCA as the predictor of fluid responsiveness.

  1 minute after PLR test and 1 minute after fluid challenge

Study Arms (1)

Acute circulatory failure

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

Diagnostic Test: fluid responsiveness assessment

Interventions

fluid responsiveness assessment DIAGNOSTIC_TEST

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.

Also known as: passive leg raise, fluid challenge

Acute circulatory failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Mechanically ventilated patients admitted to critical care unit.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Uniwersytecki Szpital Kliniczny w Opolu: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Opole, Opole Voivodeship, 45-372, Poland

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 26, 2018
• Study Start: June 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

PL (1)