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

NCT ID: NCT03412422

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-10-01

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute circulatory failure

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

fluid responsiveness assessment

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

passive leg raise; fluid challenge

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uniwersytecki Szpital Kliniczny w Opolu

OTHER

Sponsor Role: lead

Responsible Party

Maciej Piwoda

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Opole, Opole Voivodeship, Poland

Countries

Poland

Other Identifiers

CCA_USG_PLR_USK

Identifier Type: -

Identifier Source: org_study_id