NCT03766451

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

12 months

First QC Date

November 28, 2018

Last Update Submit

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

Age20 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

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

RECRUITING

Study Officials

  • Hebatullah Negm eldeen, A.L.

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

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

Locations