Assessment Of Carotid Flow During General Anesthesia

NCT03713008 | Completed

• 1 other identifier: CART
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Fluid Responsiveness

Keywords

Fluid Responsiveness, Anesthesia, Surgery, Stroke Volume Variation, Fluid status,

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in pulse pressure variation

  Before and 2 minutes after intervention

• Change in stroke volume variation

  Before and 2 minutes after intervention

• Change in a carotid blood flow

  Before and 2 minutes after intervention

• Change in a velocity time integral of carotid flow

  Before and 2 minutes after intervention

• Change in the maximal systolic carotid velocity variation

  Before and 2 minutes after intervention

Study Arms (1)

Fluid bolus

EXPERIMENTAL

Patients included in the study will receive fluid bolus.

Diagnostic Test: Fluid bolus

Interventions

Fluid bolus DIAGNOSTIC_TEST

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

Fluid bolus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major abdominal surgery
• Artery catheter required

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University Of Warsaw

Warsaw, Mazovian, 02-091, Poland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients included in the study will receive 4 ml/kg fluid bolus.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: October 22, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-10

Locations

PL (1)