The Relation Between Common Carotid Artery Diameter and Central Venous Pressure for Assessment of Intravascular Fluid Status After Major Surgeries: An Observational Study

Recently, bedside ultrasound has become an important tool for the simple and non-invasive hemodynamic assessment of critically ill patients. This applies not only to echocardiography but also to ultrasound of large extra-thoracic veins. The sonography can provide real time assessment of the vascular system and hemodynamic status at the bedside.

To our knowledge, there is one report about the association between sonographically assessed carotid artery diameter and intravascular volume, which raised recommendation for further studies including the interplay between carotid geometry and intravascular fluid status.

Aim of the study:

The aim of this work is to evaluate the accuracy of noninvasive techniques for assessment of intravascular volume status by Sonographic assessment of both the common carotid artery diameter (CCA) and the central venous pressure (CVP) in response to a bolus of crystalloid solution infusion and to find the correlation between CCA diameter and CVP as the primary outcome in adults patients after major surgeries who needs close assessment and maintenance of the intravascular volume status.

Study Overview

• Status: Unknown
• Conditions: Fluid Resuscitation Monitoring Non-invasively
• Intervention / Treatment: Diagnostic test: common carotid artery diameter measurement

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt, 62511
    • Recruiting
    • Beni Suef
    • Contact: Tarek Al Menesy, MD; Phone Number: +201141434355; Email: tarek_gada@yahoo.com
    • Sub-Investigator: Ahmed A. BAdawy, MD
    • Sub-Investigator: Ashraf A. Mawgood, MD
    • Sub-Investigator: Yasmine A. Badawy, Medical Student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients scheduled for elective or emergency major surgeries including, including (but not limited to) (abdominal exploration for intestinal obstruction or after trauma, aorto-femoral bypass, radical cystectomy, etc..) that require post-operative close monitoring, assessment and resuscitation of the intravascular volume status

Description

Inclusion Criteria:

1. Male and female patients (age 20-60 years).
2. ASA physical status I and II
3. Patients who are able to breathe spontaneously and lie supine.
4. Patients who have CVP catheter (subclavian or internal jugular vein).

Exclusion Criteria:

1. History of carotid artery surgery
2. Significant cardiac disease (cardiomyopathy and/or moderate to severe valvular heart lesion).
3. Significant hepatic disease (Child-Pugh score B or C ).
4. Renal failure.
5. Obesity: BMI ˃ 30 kg/m2
6. Need for mechanical ventilation.
7. Pregnancy.
8. Unstable vital signs during the process of sonography (e.g. the patients on vasoactive drugs)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patients admitted ti surgical ICU after major surgery; patient admitted to surgical ICU after major surgery for post-operative close monitoring, assessment and resuscitation of the intravascular volume status

Diagnostic test: common carotid artery diameter measurement; measurement of common carotid artery diameter will be carried out two times: the initial measurement (pre-infusion) which is followed by infusion of crystalloid solution (Ringer lactate) 30 ml/min till reaching a total infusion volume of 7 ml/kg body weight then another ultrasound measurement will be taken (prost-infusion). Between these sequential measurements, the patient position will not be changed. The percentage increase in CCA diameter will be calculated using the formula: [(dia-mpost/dia-mpre) × 100] - 100 [11].

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Common Carotid Artery diameter at expiration (millimetre)	common carotid artery internal diameter changes songraphically measured to assess intravenous resuscitation	30 minutes before fluid bolus infusion
Common Carotid Artery diameter at expiration (millimetre)	common carotid artery internal diameter changes songraphically measured to assess intravenous resuscitation	5 minutesafter fluid bolus infusion
Central venous pressure (centimetre water)	Central venous pressure changes measured to assess intravenous resuscitation	5 minutes after fluid bolus infusion

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2019
• Primary Completion (Anticipated): October 7, 2019
• Study Completion (Anticipated): October 7, 2019

Study Registration Dates

• First Submitted: July 7, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: FM-BSU REC: 007/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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