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Trial record 17 of 112 for:    Recruiting, Not yet recruiting, Available Studies | Common carotid artery

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

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ClinicalTrials.gov Identifier: NCT03412422
Recruitment Status : Not yet recruiting
First Posted : January 26, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Maciej Piwoda, Uniwersytecki Szpital Kliniczny w Opolu

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.

Condition or disease Intervention/treatment
Critical Illness Fluid Responsiveness Diagnostic Test: fluid responsiveness assessment

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


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:
  • passive leg raise
  • fluid challenge




Primary Outcome Measures :
  1. Changes in the diameter of the common carotid artery [ Time Frame: 1 minute after PLR test and 1 minute after fluid challenge ]
    The diameter will be measured with ultrasound


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mechanically ventilated patients admitted to critical care unit.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412422


Contacts
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Contact: Maciej Piwoda 0048774520302 mpiwoda@mp.pl

Locations
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Poland
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu Not yet recruiting
Opole, Opolskie, Poland, 45-372
Contact: Maciej Piwoda, MD    0048774520302    mpiwoda@mp.pl   
Contact: Ryszard Gawda, MD PhD         
Sub-Investigator: Tomasz Czarnik, MD PhD         
Sub-Investigator: Maciej Marszalski, MD         
Sponsors and Collaborators
Uniwersytecki Szpital Kliniczny w Opolu

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Responsible Party: Maciej Piwoda, Principal Investigator, Uniwersytecki Szpital Kliniczny w Opolu
ClinicalTrials.gov Identifier: NCT03412422     History of Changes
Other Study ID Numbers: CCA_USG_PLR_USK
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maciej Piwoda, Uniwersytecki Szpital Kliniczny w Opolu:
Passive Leg Raise
Fluid Challenge
Common carotid artery
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes