Noninvasive Assessment of Intravascular Volume Status for Postoperative Patients
1 other identifier
observational
35
1 country
1
Brief 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) . 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2018
CompletedFirst Submitted
Initial submission to the registry
November 28, 2018
CompletedFirst Posted
Study publicly available on registry
December 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedDecember 6, 2018
December 1, 2018
12 months
November 28, 2018
December 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
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
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hebatullah Negm Eldeen
Banī Suwayf, 11311, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Hebatullah Negm eldeen, A.L.
Beni-Suef University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
November 28, 2018
First Posted
December 6, 2018
Study Start
November 10, 2018
Primary Completion
November 1, 2019
Study Completion
November 1, 2019
Last Updated
December 6, 2018
Record last verified: 2018-12