Verification of the Correct Insertion of a Central Venous Catheter

NCT06109584 | Unknown

• 1 other identifier: 02-23-270-088
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheter Related Complication

Outcome Measures

Primary Outcomes (1)

• To determine the incidence of malposition of central venous catheter

  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

Study Arms (2)

CVC location with Rx

ACTIVE COMPARATOR

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

CVC location with echocardiography

ACTIVE COMPARATOR

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

Interventions

Insertion of central venous catheter DEVICE

Central venous catheter verified by ultrasound and then verified by radiography.

CVC location with Rx; CVC location with echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

RECRUITING

Study Officials

• Paula Gil Esteller, MD

  Consorci Sanitari de Terrassa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula Gil Esteller, MD

CONTACT

+34 628467708; gilesteller@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: We 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 Record Dates

• First Submitted: October 1, 2023
• First Posted: October 31, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: In 1 year, for 3 years.
• Access Criteria: Anaesthesiologists

Locations

ES (1)