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

NCT ID: NCT04018443

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-07

Study Completion Date

2019-10-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fluid Resuscitation Monitoring Non-invasively

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

common carotid artery diameter measurement

Intervention Type DIAGNOSTIC_TEST

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 \[11\].

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 \[11\].

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Samaa A. Kasem

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beni Suef

Banī Suwayf, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Samaa A. Kasem, MD

Role: CONTACT

+201270159125

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tarek Al Menesy, MD

Role: primary

+201141434355

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FM-BSU REC: 007/2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.