Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379347
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-18
Brief Title:
HOspitalized Patients and Clinical flUid Status Assessment Using Point Of Care UltraSound
Sponsor:
Flevoziekenhuis
Organization:
Flevoziekenhuis
Study Overview
Official Title:
HOspitalized Patients and Clinical flUid Status Assessment Using Point Of Care UltraSound
Status:
RECRUITING
Status Verified Date:
2024-10
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:
HOCUS-POCUS
Brief Summary:
Point of care ultrasound POCUS of the inferior vena cava IVC is a tool for assessing volume status through ultrasonography Using a point of care ultrasound device the physician can perform an ultrasound of the vena cava at the bedside Previous research has demonstrated a correlation between right atrial pressure and the vena cavas diameter Nonetheless the majority of research has been conducted in critically ill populations to predict fluid responsiveness in patients with more complex hemodynamics There is limited data available on the value of IVC ultrasound in the sub-acute setting on the regular ward for clinical decision-making regarding whether a patient is hypovolemic or hypervolemic This studys objective is to assess the diagnostic utility of point-of-care ultrasonography of the IVC by using a standardized methodology performed by qualified ward physicians in a conventional nursing ward
Detailed Description:
The study will be carried out on patients over the age of 18 who were admitted to the general ward between for at least 24 hours and who had a clinical indication for an IVC ultrasound Patients are informed through an informed consent form and are given the opportunity to opt-out When there are no objections the patients data is collected for the study Patients who are using vasopressors at the time of the ultrasound are excluded from the study In addition patients who require invasive or non-invasive ventilation optiflow CPAP BPAP are also excluded
The ultrasounds are performed by trained physicians based on a standard operating procedure The longitudinal portion of the IVC is scanned and a cine loop of 10 seconds is made during a respiratory cycle to determine the diameter of the IVC dIVC After the recording is paused the dIVC will be measured 2 cm caudal to the junction of the hepatic vein and IVC to standardize the measurements Measurements are taken at peak expiration dIVCe and inspiration dIVCi by measuring the vein lumen at one respiratory cycle from one interior wall to the opposite interior wall
Data is collected at the time of admission and after 48 hours or prematurely if the patient is discharged During the initial assessment the patients demographics clinical data physical examination vitals laboratory parameters and the POCUS IVC minimal and maximal diameter percentage collapse are registered The Charlson Comorbidity Index is used to quantify the severity of comorbidities in the patients Additionally the patients overall health status is measured by the ECOG Performance Status Scale
Once the initial measurements are done a clinical diagnosis of the patients volume status will be established 48 hours later more data will be gathered for the follow-up The data includes vitals and laboratory parameters It is also noted whether the POCUS influenced the management of treatment IV fluid or diuretic therapy of each patient Following this assessment a clinical diagnosis in retrospect at the time of the ultrasound at baseline about the volume status is established
The diagnostic accuracy for hypovolemia and hypervolemia cases are analyzed The sensitivity specificity positive predictive value and negative predictive value are also determined Furthermore the area under the curve AUC for hypo- and hypervolemia were computed
A descriptive analysis of the changes over time will be carried out in the subgroup with follow-up measurements The interpretation of the images at the time of the ultrasound serves as the foundation for the main analysis A second assessor will verify the images retrospectively in a subset recalculating the diameter and evaluating their quality A descriptive analysis will be conducted on the quality of measurements Moreover an exploratory analysis will be carried out to ascertain the best location and cutoff points for identifying volume status
The ultrasounds are performed by trained physicians based on a standard operating procedure The longitudinal portion of the IVC is scanned and a cine loop of 10 seconds is made during a respiratory cycle to determine the diameter of the IVC dIVC After the recording is paused the dIVC will be measured 2 cm caudal to the junction of the hepatic vein and IVC to standardize the measurements Measurements are taken at peak expiration dIVCe and inspiration dIVCi by measuring the vein lumen at one respiratory cycle from one interior wall to the opposite interior wall
Data is collected at the time of admission and after 48 hours or prematurely if the patient is discharged During the initial assessment the patients demographics clinical data physical examination vitals laboratory parameters and the POCUS IVC minimal and maximal diameter percentage collapse are registered The Charlson Comorbidity Index is used to quantify the severity of comorbidities in the patients Additionally the patients overall health status is measured by the ECOG Performance Status Scale
Once the initial measurements are done a clinical diagnosis of the patients volume status will be established 48 hours later more data will be gathered for the follow-up The data includes vitals and laboratory parameters It is also noted whether the POCUS influenced the management of treatment IV fluid or diuretic therapy of each patient Following this assessment a clinical diagnosis in retrospect at the time of the ultrasound at baseline about the volume status is established
The diagnostic accuracy for hypovolemia and hypervolemia cases are analyzed The sensitivity specificity positive predictive value and negative predictive value are also determined Furthermore the area under the curve AUC for hypo- and hypervolemia were computed
A descriptive analysis of the changes over time will be carried out in the subgroup with follow-up measurements The interpretation of the images at the time of the ultrasound serves as the foundation for the main analysis A second assessor will verify the images retrospectively in a subset recalculating the diameter and evaluating their quality A descriptive analysis will be conducted on the quality of measurements Moreover an exploratory analysis will be carried out to ascertain the best location and cutoff points for identifying volume status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None