Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 113 for:    Recruiting, Not yet recruiting, Available Studies | Common carotid artery

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04018443
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Samaa A. Kasem, Beni-Suef University

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.


Condition or disease Intervention/treatment
Fluid Resuscitation Monitoring Non-invasively Diagnostic Test: common carotid artery diameter measurement

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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
Actual Study Start Date : April 7, 2019
Estimated Primary Completion Date : October 7, 2019
Estimated Study Completion Date : October 7, 2019

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].




Primary Outcome Measures :
  1. Common Carotid Artery diameter at expiration (millimetre) [ Time Frame: 30 minutes before fluid bolus infusion ]
    common carotid artery internal diameter changes songraphically measured to assess intravenous resuscitation

  2. Common Carotid Artery diameter at expiration (millimetre) [ Time Frame: 5 minutesafter fluid bolus infusion ]
    common carotid artery internal diameter changes songraphically measured to assess intravenous resuscitation

  3. Central venous pressure (centimetre water) [ Time Frame: 5 minutes after fluid bolus infusion ]
    Central venous pressure changes measured to assess intravenous resuscitation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018443


Contacts
Layout table for location contacts
Contact: Samaa A. Kasem, MD +201270159125 sama.a.kasem@gmail.com

Locations
Layout table for location information
Egypt
Beni Suef Recruiting
Banī Suwayf, Egypt, 62511
Contact: Tarek Al Menesy, MD    +201141434355    tarek_gada@yahoo.com   
Sub-Investigator: Ahmed A. BAdawy, MD         
Sub-Investigator: Ashraf A. Mawgood, MD         
Sub-Investigator: Yasmine A. Badawy, Medical Student         
Sponsors and Collaborators
Beni-Suef University

Layout table for additonal information
Responsible Party: Samaa A. Kasem, Associate professor, Beni-Suef University
ClinicalTrials.gov Identifier: NCT04018443     History of Changes
Other Study ID Numbers: FM-BSU REC: 007/2019
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No