Assessment Of Carotid Flow During General Anesthesia

Assessment of Fluid Responsiveness With Carotid Flow Change During General Anaesthesia

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Fluid Responsiveness
• Intervention / Treatment: Diagnostic test: Fluid bolus

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Mazovian
    • Warsaw, Mazovian, Poland, 02-091
      • Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiac output	A measure of change of scaled cardiac output (nCO) with LiDCO device	Before and 2 minutes after intervention
Change in a corrected carotid artery flow	Ultrasound measure of corrected carotid artery flow time	Before and 2 minutes after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pulse pressure variation	A measure of change of pulse pressure variation (PPV) with LiDCO device	Before and 2 minutes after intervention
Change in stroke volume variation	A measure of change of pulse pressure variation with LiDCO device	Before and 2 minutes after intervention
Change in a carotid blood flow	Ultrasound measure of corrected carotid blood flow time	Before and 2 minutes after intervention
Change in a velocity time integral of carotid flow	Ultrasound measure of velocity time integral of carotid flow	Before and 2 minutes after intervention
Change in the maximal systolic carotid velocity variation	Ultrasound measure of the maximal systolic carotid velocity variation	Before and 2 minutes after intervention

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Fluid Responsiveness, Anesthesia, Surgery, Stroke Volume Variation, Fluid status,
• Other Study ID Numbers: CART

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No