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Completed

NCT Number: NCT03713008

Assessment Of Carotid Flow During General Anesthesia

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.

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Key information

Conditions

Anesthesia Fluid Responsiveness

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Of Warsaw

Warsaw, Mazovian, 02-091, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid bolus

Diagnostic Test

All patients included in the study will receive 5 ml/kg fluid bolus of a balanced crystalloid solution.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Assessment of Fluid Responsiveness With Carotid Flow Change During General Anaesthesia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2018
Registry last updated
Oct 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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