Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter. (DISLOTIP)

February 26, 2025 updated by: Francesco Raimondi, Federico II University

Use of Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter: a Multicentric Study

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

Study Overview

Status

Completed

Conditions

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 Gauge/1 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 Type

Observational

Enrollment (Actual)

217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • AOU Federico II- Neonatal Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

neonates undergoing placement of 28G/1 Fr ECCs with a standardized securement system

Description

Inclusion Criteria:

  • neonates undergoing placement of 28 G/1 Fr ECCs with a standardized securement system

Exclusion Criteria:

  • neonates with major malformation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of cases in which ultrasound tip location is feasible to study ECC secondary malposition
Time Frame: 8 days from the ECC placement
percentage, from 0% to 100%
8 days from the ECC placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2024

Primary Completion (Actual)

October 15, 2024

Study Completion (Actual)

October 15, 2024

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Protocol 335

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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