Intravascular VolumeNCT03766451
Noninvasive Assessment of Intravascular Volume Status for Postoperative Patients
An observational study of Intravascular Volume, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Ultrasound measurements of the inferior vena cava (IVC) have been proposed as a noninvasive tool to help guide fluid management. Well-established correlations exist between respiratory cycle-induced changes in IVC diameter and C entral Venous Pressure (CVP) . Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Intravascular Volume
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2018to Nov 2019
- 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
- Adult
Study population: Patients scheduled for elective or emergency major surgeries (e.g., abdominal exploration, cancer bladder, cancer rectum, cancer stomach and aorto-femoral bypass grafting) who require post-operative SICU admission for close monitoring and assessment of volume status will be considered for enrollment.
Who may be able to join
- ASA physical status I and II
- Patients who are able to breathe spontaneously and lay supine post-operative.
- Patients who had CVP catheter (subclavian or internal jugular vein)
Who cannot join
- 1- Chronic obstructive or restrictive pulmonary disease. 2-Significant cardiac disease 3-Significant hepatic disease 4-Renal impairment ( creatinine >2 mg/dl). 5- BMI ˃ 30 kg/m2 6- Pneumothorax or mediastinal masses. 7- mechanical ventilation or coming with tracheostomy. 8- defect at the site of sonography. 9- Pregnancy. 10- Instability of vital signs 11- Unwillingness to participate 12- sepsis or septic shock. 13- neurosurgical interventions
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Hebatullah Negm Eldeen
Banī Suwayf, 11311
samaa rashwan, A.P, 01208929154, samaarashwan1971@gmail.com
Ahmed Goda, MD, 01111861863, Abogoda100100@yahoo.com
About this study
Official title: Noninvasive Assessment of Intravascular Volume Status for Postoperative Patients: The Correlation Between Internal Jugular Vein/Common Carotid Artery Cross-Sectional Area Ratio and the Inferior Vena Cava Diameter
Ultrasound measurements of the inferior vena cava (IVC) have been proposed as a noninvasive tool to help guide fluid management. Well-established correlations exist between respiratory cycle-induced changes in IVC diameter and C entral Venous Pressure (CVP) . Beyond providing an estimate of CVP, the caval index, or percentage collapsibility of the IVC , has been proposed as a predictor of preload reserve. This noninvasive rapid measurement of CVP is especially important in critical care settings. It can help in differentiating hypovolemic, septic and cardiogenic shock. Changes in volume status will be depicted by change in the diameter of the IVC .
However, the validity and reliability of sonographic assessment of the inferior vena cava have been matters of controversy, and its applicability has been shown to be limited by technical difficulties. Recent study has shown a significant relationship between the internal jugular vein/common carotid artery (IJV/CCA) cross-sectional area ratio and CVP in pediatric burn patients .
Read the detailed description
Type and Site of The study:
This study will be be done at Beni-Suef university hospital ,Surgical Intensive Care Unit (SICU) after approval of the local ethics and research committee and anesthesia department of Beni- Suef University.
DATE AND PERIOD OF THE STUDY:
The study will be done between NOV. 2018 and Nov. 2019
Patients will be included:
Patients scheduled for elective or emergency major surgeries (e.g., abdominal exploration, cancer bladder, cancer rectum, cancer stomach and aorto-femoral bypass grafting) who require post-operative SICU admission for close monitoring and assessment of volume status will be considered for enrollment.
Thirty five patients will be enrolled in the study; the patients will be admitted to the post-surgical intensive care unit for post-operative close observation and monitoring for at least 24 h. Upon admission, baseline laboratory investigation, chest x-ray, Arterial Blood Gases (ABG) and vital signs (hear rate, mean arterial blood pressure, arterial oxygen saturation and temperature) will be all measured.
Patients will get nurse-controlled analgesia using morphine boluses of 1-2 mg intravenously, followed by a continuous infusion of 1 or 2 mg/h according to the protocol of the SICU team. CVP, sonographic measurement of (IJV/CCA) cross sectional area ratio and IVC diameter will be measured after admitting the patient to SICU as a baseline reading, second measurements will be after achieving CVP between (8-12 cmH2O).
Data to be collected and measured
Demographic data will be obtained from patient's notes and charts including
1- Age, sex, body mass index, ASA physical status and type of surgery.
Cardiorespiratory variables of the Patients include:
- CVP (CMH2O),
- Heart rate (beats/min),
- MAP( mmHg),
- Oxygen saturation (spo2 %),
- Urine output (ml/h),
IVC measurements include:
- IVC Maximum Diameter (cm).
- IVC Minimum Diameter (cm).
Internal jugular vein and common carotid artery measurements include:
- CCA Surface
- IJV surface at inspiration
- IJV surface at expiration
- IJV/CCA RATIO at inspiration
- IJV/CCA RATIO at expiration
Data will be measured after admitting the patient to SICU as a baseline reading, second measurements will be after achieving CVP between (8-12 cmH2O).
- Conditions
- Intravascular Volume
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between (Internal Jugular Vein/Common Carotid Artery Cross-Sectional Area Ratio),and Inferior Vena Cava Diameter by using ultrasound
The correlation between (Internal Jugular Vein/Common Carotid Artery Cross-Sectional Area Ratio),and Inferior Vena Cava Diameter by using ultrasound
Measured: immediately upon admission to surgical intensive care unit and after acchieving cvp above 8 cmh2o by saline infusion (10 ml/kg) average 3 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start10 Nov 2018
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravascular VolumeStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatullah Negm Eldeen Abd El Azeem, Beni-Suef University
- Investigators
- Hebatullah Negm eldeen, A.L., Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766451
- Sponsor's protocol ID
- Hebatullah Negm Eldeen
- Status last verified
- Dec 2018
- First submitted
- 28 Nov 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Assessment of Intravascular Volume Status for Postoperative Patients: The Correlation Between Internal Jugular Vein/Common Carotid Artery Cross-Sectional Area Ratio and the Inferior Vena Cava Diameter
- ClinicalTrials.gov ID
- NCT03766451
- Acronym / sponsor ID
- Hebatullah Negm Eldeen
- Conditions
- Intravascular Volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 6 Dec 2018 (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.
Ultrasound measurements of the inferior vena cava (IVC) have been proposed as a noninvasive tool to help guide fluid management. Well-established correlations exist between respiratory cycle-induced changes in IVC diameter and C entral Venous Pressure (CVP) . Beyond providing an estimate of CVP, the caval index, or percentage collapsibility of the IVC , has been proposed as a predictor of preload reserve. This noninvasive rapid measurement of CVP is especially important in critical care settings. It can help in differentiating hypovolemic, septic and cardiogenic shock. Changes in volume status will be depicted by change in the diameter of the IVC .
However, the validity and reliability of sonographic assessment of the inferior vena cava have been matters of controversy, and its applicability has been shown to be limited by technical difficulties. Recent study has shown a significant relationship between the internal jugular vein/common carotid artery (IJV/CCA) cross-sectional area ratio and CVP in pediatric burn patients .
Detailed description
Type and Site of The study:
This study will be be done at Beni-Suef university hospital ,Surgical Intensive Care Unit (SICU) after approval of the local ethics and research committee and anesthesia department of Beni- Suef University.
DATE AND PERIOD OF THE STUDY:
The study will be done between NOV. 2018 and Nov. 2019
Patients will be included:
Patients scheduled for elective or emergency major surgeries (e.g., abdominal exploration, cancer bladder, cancer rectum, cancer stomach and aorto-femoral bypass grafting) who require post-operative SICU admission for close monitoring and assessment of volume status will be considered for enrollment.
Thirty five patients will be enrolled in the study; the patients will be admitted to the post-surgical intensive care unit for post-operative close observation and monitoring for at least 24 h. Upon admission, baseline laboratory investigation, chest x-ray, Arterial Blood Gases (ABG) and vital signs (hear rate, mean arterial blood pressure, arterial oxygen saturation and temperature) will be all measured.
Patients will get nurse-controlled analgesia using morphine boluses of 1-2 mg intravenously, followed by a continuous infusion of 1 or 2 mg/h according to the protocol of the SICU team. CVP, sonographic measurement of (IJV/CCA) cross sectional area ratio and IVC diameter will be measured after admitting the patient to SICU as a baseline reading, second measurements will be after achieving CVP between (8-12 cmH2O).
Data to be collected and measured
Demographic data will be obtained from patient's notes and charts including
1- Age, sex, body mass index, ASA physical status and type of surgery.
Cardiorespiratory variables of the Patients include:
- CVP (CMH2O),
- Heart rate (beats/min),
- MAP( mmHg),
- Oxygen saturation (spo2 %),
- Urine output (ml/h),
IVC measurements include:
- IVC Maximum Diameter (cm).
- IVC Minimum Diameter (cm).
Internal jugular vein and common carotid artery measurements include:
- CCA Surface
- IJV surface at inspiration
- IJV surface at expiration
- IJV/CCA RATIO at inspiration
- IJV/CCA RATIO at expiration
Data will be measured after admitting the patient to SICU as a baseline reading, second measurements will be after achieving CVP between (8-12 cmH2O).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients scheduled for elective or emergency major surgeries (e.g., abdominal exploration, cancer bladder, cancer rectum, cancer stomach and aorto-femoral bypass grafting) who require post-operative SICU admission for close monitoring and assessment of volume status will be considered for enrollment.
Key inclusion criteria (3 listed)
- ASA physical status I and II
- Patients who are able to breathe spontaneously and lay supine post-operative.
- Patients who had CVP catheter (subclavian or internal jugular vein)
Key exclusion criteria (1 listed)
- 1- Chronic obstructive or restrictive pulmonary disease. 2-Significant cardiac disease 3-Significant hepatic disease 4-Renal impairment ( creatinine >2 mg/dl). 5- BMI ˃ 30 kg/m2 6- Pneumothorax or mediastinal masses. 7- mechanical ventilation or coming with tracheostomy. 8- defect at the site of sonography. 9- Pregnancy. 10- Instability of vital signs 11- Unwillingness to participate 12- sepsis or septic shock. 13- neurosurgical interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation between (Internal Jugular Vein/Common Carotid Artery Cross-Sectional Area Ratio),and Inferior Vena Cava Diameter by using ultrasound
Time frame: immediately upon admission to surgical intensive care unit and after acchieving cvp above 8 cmh2o by saline infusion (10 ml/kg) average 3 hours after admission
The correlation between (Internal Jugular Vein/Common Carotid Artery Cross-Sectional Area Ratio),and Inferior Vena Cava Diameter by using ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
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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.
Hebatullah Negm eldeen, A.L. principal investigator
Beni-Suef University
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 Intravascular Volume, 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 3 inclusion and 1 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 6 Dec 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between (Internal Jugular Vein/Common Carotid Artery Cross-Sectional Area Ratio),and Inferior Vena Cava Diameter by using ultrasound (time frame: immediately upon admission to surgical intensive care unit and after acchieving cvp above 8 cmh2o by saline infusion (10 ml/kg) average 3 hours after admission). 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 6 Dec 2018.