Fluid Resuscitation Monitoring Non-invasivelyNCT04018443
The Relation Between Common Carotid Artery Diameter and Central Venous Pressure for Assessment of Intravascular Fluid Status After Major Surgeries: An Observational Study
An observational study of Fluid Resuscitation Monitoring Non-invasively, run by Beni-Suef University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Fluid Resuscitation Monitoring Non-invasively
- What is being tested?
- common carotid artery diameter measurement
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Apr 2019to 7 Oct 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- Male and female patients (age 20-60 years).
- ASA physical status I and II
- Patients who are able to breathe spontaneously and lie supine.
- Patients who have CVP catheter (subclavian or internal jugular vein).
Who cannot join
- History of carotid artery surgery
- Significant cardiac disease (cardiomyopathy and/or moderate to severe valvular heart lesion).
- Significant hepatic disease (Child-Pugh score B or C ).
- Renal failure.
- Obesity: BMI ˃ 30 kg/m2
- Need for mechanical ventilation.
- Pregnancy.
- Unstable vital signs during the process of sonography (e.g. the patients on vasoactive drugs)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni Suef
Banī Suwayf, 62511
Tarek Al Menesy, MD, +201141434355, tarek_gada@yahoo.com
Ahmed A. BAdawy, MD
About this 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.
Read more
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.
- Being tested
- common carotid artery diameter measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
common carotid artery diameter measurementDiagnostic 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].
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: common carotid artery diameter measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common Carotid Artery diameter at expiration (millimetre)
common carotid artery internal diameter changes songraphically measured to assess intravenous resuscitation
Measured: 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
Measured: 5 minutesafter fluid bolus infusion
Central venous pressure (centimetre water)
Central venous pressure changes measured to assess intravenous resuscitation
Measured: 5 minutes after fluid bolus infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start7 Apr 2019
- Primary completion7 Oct 2019 (estimated)
- Study completion7 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid Resuscitation Monitoring Non-invasivelyStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaa A. Kasem, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018443
- Sponsor's protocol ID
- FM-BSU REC: 007/2019
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04018443
- Acronym / sponsor ID
- FM-BSU REC: 007/2019
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 7 Apr 2019 (actual)
- Primary completion
- 7 Oct 2019 (estimated)
- Study completion
- 7 Oct 2019 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients admitted ti surgical ICU after major surgery | – | Diagnostic Test: common carotid artery diameter measurementpatient admitted to surgical ICU after major surgery for post-operative close monitoring, assessment and resuscitation of the intravascular volume status |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- Male and female patients (age 20-60 years).
- ASA physical status I and II
- Patients who are able to breathe spontaneously and lie supine.
- Patients who have CVP catheter (subclavian or internal jugular vein).
Key exclusion criteria (8 listed)
- History of carotid artery surgery
- Significant cardiac disease (cardiomyopathy and/or moderate to severe valvular heart lesion).
- Significant hepatic disease (Child-Pugh score B or C ).
- Renal failure.
- Obesity: BMI ˃ 30 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| common carotid artery diameter measurementmeasurement 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]. | Diagnostic test | patients admitted ti surgical ICU after major surgery |
Primary outcome
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
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
Central venous pressure (centimetre water)
Time frame: 5 minutes after fluid bolus infusion
Central venous pressure changes measured to assess intravenous resuscitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Resuscitation Monitoring Non-invasively, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samaa A. Kasem, MD (+201270159125, sama.a.kasem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common Carotid Artery diameter at expiration (millimetre) (time frame: 30 minutes before fluid bolus infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.