Verification of the Correct Insertion of a Central Venous Catheter

Sponsor

Consorci Sanitari de Terrassa (Other)

Overall Status

Recruiting

CT.gov ID

NCT06109584

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Catheter Related Complication	Device: Insertion of central venous catheter	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

To determine the incidence of malposition of central venous catheter [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Consorci Sanitari de Terrassa	Terrassa	Barcelona	Spain	08227

Sponsors and Collaborators

Consorci Sanitari de Terrassa

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paula Gil Esteller, Principal Investigator, Clinical Professor, Consorci Sanitari de Terrassa

ClinicalTrials.gov Identifier:

NCT06109584

Other Study ID Numbers:

02-23-270-088

First Posted:

Oct 31, 2023

Last Update Posted:

Oct 31, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 31, 2023