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Assessment Of Carotid Flow During General Anesthesia

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ClinicalTrials.gov Identifier: NCT03713008
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Brief Summary:
Proper identification of patients who would benefit from fluid infusion (fluid responsiveness) is one of the most crucial challenges in anaesthesia and critical care. Reliability of several invasive measurements used for this purpose for many years have been questioned recently. The study will evaluate consistency between carotid artery flow derivatives and standard haemodynamic measurement (LIDCO rapid) in navigation of intraoperative fluid therapy.

Condition or disease Intervention/treatment Phase
Anesthesia Fluid Responsiveness Diagnostic Test: Fluid bolus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All patients included in the study will receive 4 ml/kg fluid bolus.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Fluid Responsiveness With Carotid Flow Change During General Anaesthesia
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Fluid bolus
Patients included in the study will receive fluid bolus.
Diagnostic Test: Fluid bolus
All patients included in the study will receive 5 ml/kg fluid bolus of a balanced crystalloid solution.




Primary Outcome Measures :
  1. Change in cardiac output [ Time Frame: Before and 2 minutes after intervention ]
    A measure of change of scaled cardiac output (nCO) with LiDCO device

  2. Change in a corrected carotid artery flow [ Time Frame: Before and 2 minutes after intervention ]
    Ultrasound measure of corrected carotid artery flow time


Secondary Outcome Measures :
  1. Change in pulse pressure variation [ Time Frame: Before and 2 minutes after intervention ]
    A measure of change of pulse pressure variation (PPV) with LiDCO device

  2. Change in stroke volume variation [ Time Frame: Before and 2 minutes after intervention ]
    A measure of change of pulse pressure variation with LiDCO device

  3. Change in a carotid blood flow [ Time Frame: Before and 2 minutes after intervention ]
    Ultrasound measure of corrected carotid blood flow time

  4. Change in a velocity time integral of carotid flow [ Time Frame: Before and 2 minutes after intervention ]
    Ultrasound measure of velocity time integral of carotid flow

  5. Change in the maximal systolic carotid velocity variation [ Time Frame: Before and 2 minutes after intervention ]
    Ultrasound measure of the maximal systolic carotid velocity variation



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major abdominal surgery
  • Artery catheter required

Exclusion Criteria:

  • Laparoscopic surgery
  • Known history of carotid endarterectomy
  • Known history of carotid stenosis
  • Non-sinus rhythm
  • Systolic or diastolic heart failure
  • Chronic kidney disease
  • Pulmonary hypertension
  • Carotid artery anomaly
  • Unable to visualise carotid artery
  • Angle of correction > 60

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): NCT03713008


Locations
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Poland
Medical University Of Warsaw Recruiting
Warsaw, Mazovian, Poland, 02-091
Contact: Mateusz Zawadka, MD    225992002    anestezjologia.banacha@gmail.com   
Principal Investigator: Paweł Andruszkiewicz, PhD         
Sponsors and Collaborators
Medical University of Warsaw

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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03713008     History of Changes
Other Study ID Numbers: CART
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: May 2018

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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 Medical University of Warsaw:
Fluid Responsiveness, Anesthesia, Surgery, Stroke Volume Variation, Fluid status,

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs