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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03412422
• Other study ID #: CCA_USG_PLR_USK
• Status: Withdrawn
• Start date: June 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2020
• Source: Uniwersytecki Szpital Kliniczny w Opolu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Fluid Responsiveness

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu	Opole	Opolskie

Sponsors (1)

Lead Sponsor	Collaborator
Uniwersytecki Szpital Kliniczny w Opolu

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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