Clinical trial NCT04018443: The Relation Between Common Carotid Artery Diameter and Central Venous Pressure for Assessment of Intravascular Fluid Status After Major Surgeries: An Observational Study
Official title: The Relation Between Common Carotid Artery Diameter and Central Venous Pressure for Assessment of Intravascular Fluid Status After Major Surgeries: An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fluid Resuscitation Monitoring Non-invasively
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Common Carotid Artery diameter at expiration (millimetre)
timeFrame: 30 minutes before fluid bolus infusion
measure: Common Carotid Artery diameter at expiration (millimetre)
timeFrame: 5 minutesafter fluid bolus infusion
measure: Central venous pressure (centimetre water)
timeFrame: 5 minutes after fluid bolus infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni Suef
Study officials:
References: