Verification of the Correct Insertion of a Central Venous Catheter

October 28, 2023 updated by: Paula Gil Esteller, Consorci Sanitari de Terrassa

Verification of the Correct Insertion of a Supradiaphragmatic Central Venous Catheter by a Single Echocardiographic Plane

The investigators propose a prospective diagnostic validity study in which the correct location of the central venous catheter will be verified by ultrasound and then verified by radiography in the same patient, without modifying the usual clinical practice criteria.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Recruiting
        • Consorci Sanitari de Terrassa
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over 18 years of age in whom a decision is made to place a supradiaphragmatic central venous catheter.
  • Patients who agree to participate in the study

Exclusion Criteria:

  • Patients with devices that may interfere with the ultrasound images.
  • Patients with poor ultrasound window
  • Patients with superior vena cava syndrome

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CVC location with Rx
After placement of the CVC we will perform the X-ray and subsequent verification of the correct location. Simultaneously, a stopwatch will be started to calculate the time interval until the interpretation of the X-ray by the anesthesiologist.
Device: Insertion of central venous catheter
Central venous catheter verified by ultrasound and then verified by radiography.
Active Comparator: CVC location with echocardiography
Cardiac ultrasound will be performed to visualize the correct position of the CVC tip, and the time until the interpretation of the ultrasound results will also be monitored.
Device: Insertion of central venous catheter
Central venous catheter verified by ultrasound and then verified by radiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the incidence of malposition of central venous catheter
Time Frame: Through study completion, an average of 1 year
Incidence of malposition measured by echocardiography and chest radiography in confirming the correct positioning of the tip of the supradiaphragmatic central venous catheter. Moreover, this check can be performed in a shorter time interval.
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Consorci Sanitari de Terrassa

Investigators

  • Principal Investigator: Paula Gil Esteller, MD, Consorci Sanitari de Terrassa

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)

August 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

October 1, 2023

First Submitted That Met QC Criteria

October 28, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 28, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 02-23-270-088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes

IPD Sharing Time Frame

In 1 year, for 3 years.

IPD Sharing Access Criteria

Anaesthesiologists

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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