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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04018443
Other study ID # FM-BSU REC: 007/2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 7, 2019
Est. completion date October 7, 2019

Study information

Verified date July 2019
Source Beni-Suef University
Contact Samaa A. Kasem, MD
Phone +201270159125
Email sama.a.kasem@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 7, 2019
Est. primary completion date October 7, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Fluid Resuscitation Monitoring Non-invasively

Intervention

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].

Locations

Country Name City State
Egypt Beni Suef Bani Suwayf

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Common Carotid Artery diameter at expiration (millimetre) common carotid artery internal diameter changes songraphically measured to assess intravenous resuscitation 5 minutesafter fluid bolus infusion
Primary Central venous pressure (centimetre water) Central venous pressure changes measured to assess intravenous resuscitation 5 minutes after fluid bolus infusion