Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267644
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
2005-12-19
Brief Title:
Ultrasound of the Inferior Vena Cava IVC and Dehydration Status in Pediatric Emergency Patients
Sponsor:
Antonios Likourezos
Organization:
Maimonides Medical Center
Study Overview
Official Title:
Ultrasound of the Inferior Vena Cava IVC and Dehydration Status in Pediatric Emergency Patients
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective Although approximately 9 of patients presenting to a Pediatric Emergency Department ED are dehydrated there is no reliable method to measure objectively the degree of intravascular dehydration Respiratory changes in Inferior Vena Cava IVC diameter have been shown to predict volume status in adults Previous research has demonstrated correlation between IVC diameter and volume status in children undergoing hemodialysis Other studies have shown that IVC diameter in children can be sonographically measured rapidly and accurately by ED physicians If we can establish that IVC diameter predicts volume status in dehydrated children this tool could assist the ED physician in rapid diagnosis and prompt resuscitation without the need to wait for blood or urine tests In this study we use the dehydrated patient as a model for hypovolemia with the idea that the data could ultimately be used in the setting of any hypovolemic state We aim to evaluate whether ultrasound of the pediatric IVC can be used to reliably assess volume status
Methods This is a prospective cohort study Pediatric ED patients ranging in age from 1 to 41 months were assessed by a Pediatric emergency physician and stratified as either clinically euvolemic or hypovolemic After consent was obtained one of three Emergency Medicine Residents performed trans-abdominal sonographic measurements of the IVC diameter Measurements of the IVC diameter just caudal to the insertion of the hepatic veins were obtained in a longitudinal orientation
Methods This is a prospective cohort study Pediatric ED patients ranging in age from 1 to 41 months were assessed by a Pediatric emergency physician and stratified as either clinically euvolemic or hypovolemic After consent was obtained one of three Emergency Medicine Residents performed trans-abdominal sonographic measurements of the IVC diameter Measurements of the IVC diameter just caudal to the insertion of the hepatic veins were obtained in a longitudinal orientation
Detailed Description:
Ultrasound is considered a routine procedure in the ED In MMC all ultrasound done by ED staff is documented however patients are not billed for it All the ultrasound images for this study will have to be approved by Dr Marshall prior to inclusion into the study
For the purposes of this study trans-abdominal ultrasonographic measurements of the Inferior Vena Cava IVC will be taken in patients suspected of being Dehydrated The Triage Nurse will be the person who would identify acutely dehydrated patient Once a potential candidate is identified The Attending physician in the pediatric ED will be notified If a sonographer is available in the ED at the time and heshe is freewilling to perform the sonogram only then will the attending physician will notify and consent the patient
The first phase of the study will concentrate on establishing the correlation between collapsed IVC and level of dehydration During the first part of the study ultrasonography will be performed once prior to hydration
During this phase we will also perform sonograms on a control group The Control Group will consist of children aged 1 month to 3 years age who we do not suspect of being dehydrated based on initial evaluation and presenting complaints
During the second phase of the study we will measure the change in IVC diameter with fluid resuscitation During this time additional ultrasonography will be performed after adequate fluid resuscitation
Return Visit For the patient that qualify for a return visit for a weight check upon arrival to the ED will bypass registration and report to the triage nurse and identify themselves where they will be weighed and then promptly sent home
Who needs a return visit Any patient who is not admitted or does not have a recent weight available at the PMDs office prior to the onset of the current condition will qualify for a return visit The patients who has a recent weight taken at the PMDs office will be requested to sign the hospitals standard consent for transfer of the data via fax from the PMDs office
For the purposes of this study trans-abdominal ultrasonographic measurements of the Inferior Vena Cava IVC will be taken in patients suspected of being Dehydrated The Triage Nurse will be the person who would identify acutely dehydrated patient Once a potential candidate is identified The Attending physician in the pediatric ED will be notified If a sonographer is available in the ED at the time and heshe is freewilling to perform the sonogram only then will the attending physician will notify and consent the patient
The first phase of the study will concentrate on establishing the correlation between collapsed IVC and level of dehydration During the first part of the study ultrasonography will be performed once prior to hydration
During this phase we will also perform sonograms on a control group The Control Group will consist of children aged 1 month to 3 years age who we do not suspect of being dehydrated based on initial evaluation and presenting complaints
During the second phase of the study we will measure the change in IVC diameter with fluid resuscitation During this time additional ultrasonography will be performed after adequate fluid resuscitation
Return Visit For the patient that qualify for a return visit for a weight check upon arrival to the ED will bypass registration and report to the triage nurse and identify themselves where they will be weighed and then promptly sent home
Who needs a return visit Any patient who is not admitted or does not have a recent weight available at the PMDs office prior to the onset of the current condition will qualify for a return visit The patients who has a recent weight taken at the PMDs office will be requested to sign the hospitals standard consent for transfer of the data via fax from the PMDs office
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None