Ultrasound Guidance Versus Anatomical Landmarks for CVC Catheterisation:

November 8, 2020 updated by: Francesco Forfori, University of Pisa

Ultrasound Guidance Versus Anatomical Landmarks for Succlavic and Femoral Vein Catheterisation: an Observational Prospective Study

anatomical landmarks on the body surface were used to insert central vein catheter. However, ultrasound technique is emerging as a new technique for vein catheterisation. For subclavian and femoral vein catheterisation, up to now, there is a lack of evidence of the superiority of one technique over the other.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

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
      • Pisa, Italy
        • Francesco Forfori

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

intensive care patients

Description

Inclusion Criteria:

  • patients needing CVC

Exclusion Criteria:

  • refusal of consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ultrasound
CVC insertion using ultrasound
Procedure: Central vein catheterisation
ultrasound guided versus landmark central vein catheterisation
landmark technique
CVC insertion using landmark technique
Procedure: Central vein catheterisation
ultrasound guided versus landmark central vein catheterisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The success rate for succlavic or femoral vein catetherisation using ultrasound versus landmark technique at the first attempt
Time Frame: during catheterization procedure
success rate
during catheterization procedure

Collaborators and Investigators

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

Sponsor

University of Pisa

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)

May 10, 2018

Primary Completion (ACTUAL)

January 10, 2019

Study Completion (ACTUAL)

October 10, 2019

Study Registration Dates

First Submitted

July 2, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (ACTUAL)

July 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 8, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • UPisa - subclavian/femoral

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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