Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438289
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-24
Brief Title:
Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Use of Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter a Multicentric Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
DISLOTIP
Brief Summary:
This is a non-pharmacological non-profit prospective observational multicenter study Primarily the study aims to demonstrate the feasibility of ultrasound methodology to study the secondary malposition of epicutaneous-caval catheters ECC in neonates
After obtaining informed consent the study involves performing ultrasound tip location on newborns who had an ECC placed This will occur immediately after the placement and if in a central position subsequently at 60-120 minutes 48-72 hours and 6-8 days post-placement Data will be collected on various variables Each Center will contribute at least 20 cases to the cohort and all data will be recorded in a database The study is expected to last for 12 months
After obtaining informed consent the study involves performing ultrasound tip location on newborns who had an ECC placed This will occur immediately after the placement and if in a central position subsequently at 60-120 minutes 48-72 hours and 6-8 days post-placement Data will be collected on various variables Each Center will contribute at least 20 cases to the cohort and all data will be recorded in a database The study is expected to last for 12 months
Detailed Description:
Epicutaneous-caval catheters ECCs are among the most common central venous catheters used in neonatology It is known that they can experience malpositioning over time from the moment of placement leading to complications In all studies conducted so far tip location has been performed using X-ray Ultrasound would be the ideal method for serial bedside and radiatIon-free evaluation of ECC tip location to intercept any migrations The primary endpoint of the study is to demonstrate the feasibility of ultrasound method for the assessment of secondary ECC malposition Secondary endpoints include validating the results of previous Investigators monocentric study on the feasibility of ultrasound tip location applied to ECC and establishing the incidence of secondary malpositioning and the optimal timing for reassessing tip position after ECC placement All neonates undergoing placement of 28 Gauge1 French ECCs with a standardized securement system are included in the study while neonates with major malformation are excluded The study includes obtaining written informed consent performing ultrasound tip location using a standardized protocol high right parasternal apical four-chamber short-axis left parasternal and bicaval subcostal views If the tip is in a central position repeating ultrasound tip location using the same protocol at 60-120 minutes 48-72 hours and 6-8 days post-placement collecting variables including sex site of ECC insertion weight at placement and at each tip location postmenstrual age at placement and at each tip location days of life at placement and at each tip location respiratory support at placement and at each tip location feasibility of ultrasound tip location for each ECC and for each specified time ultrasound tip location result for each ECC and for each specified time and any displacement relative to the time of placement as wall as any reported complications associated with secondary malpositioning All ultrasound will be performed with the newborn in a standardized position limb adducted and elbow extended if the catheter is placed from the upper limb limb adducted and knee extended if the catheter is placed from the lower limb neutral position if the catheter is placed from the scalp The records of the ultrasound exams at each time for the first five cases enrolled by each Center will be sent to the Coordinator Center for evaluation of protocol compliance Using the exact binomial method and setting a margin of error of 4 for a 95 of confidence interval the investigators calculated that the sample size should be 196 The collected data will be recorded anonymously in an Excel database Continuous variables will be expressed as means with minimum and maximum ranges while categorical variables will be expressed as frequencies with percentages Each case will be identified with an alphanumeric code to ensure data confidentiality The principal investigator is the only person able to link the code to the identity of the patient Parents relative or guardians of eligible patients will be provided with all explanations regarding the experimental protocol by the study staff before enrollment Information will be provided and parents will be given up to 12 hours to give their consent The principal investigator will be responsible for the overall monitoring of data and the safety of the study participants No funding or additional costs beyond common current practice are anticipated
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