Ultrasound-guided Blood Sampling Drawing for Microbiological Analysis in the Critically Ill (ECOVEN)

March 10, 2025 updated by: LA BELLA MARIACARMEN, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Use of Ultrasound for Blood Sample Drawing for Microbiological Analysis in Critically Ill Patients:he ECOVEN Feasibility Study

This study will test the feasibility of ultrasound-guided sterile blood sampling for critically ill patients with suspected sepsis requiring blood culture. The aim of the study is to evaluate the feasibility and safety of the use of ultrasound for blood cultures in a population of patients which can present difficult venous access and requiring more than one venipuncture attempt in general clinical practice

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

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

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

Sampling Method

Non-Probability Sample

Study Population

Alla adult patients admitted to ICU with a suspected sepsis will be enrolled, when treating physician will prescribe blood culture for microbiological analysis

Description

Inclusion Criteria:

  • Adult patients (18 year-old)
  • admitted to intensive care unit
  • suspected sepsis requiring blood cultrure

Exclusion Criteria:

  • pregnancy
  • infections requiring respiratory isolation
  • burns or skin disease involving arms and/or more than 60% of body surface

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
Patient requiring blood culture
After the request of treating physician of blood culture, each patient deemed eligible, will undergo the prescirbed couple of peripheral blood samples. The first one will be done with the classical blind technique, while the second one with ultrasound guidance.
Diagnostic test: Ultrasound-guided venipuncture
Venipuncture will be performed using ultrasound to identify the most appropriate vessel and guide the puncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of attempted venipunctures
Time Frame: One hour after clinical decision of blood culture execution
Evaluation of the feasibility of ultrasound-guided venipuncture for blood samples in patients requiring ,microbiological analysis. Feasibility will be evaluated in terms of number of needed attempts of venipuncture
One hour after clinical decision of blood culture execution

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of possible complications (accidental arterial puncture, visible ematoma)
Time Frame: One hour after clinical decision of blood culture execution
Evaluation of safety of venipuncture in terms of possible complications (accidental arterial puncture, ematoma)
One hour after clinical decision of blood culture execution
Incidence of contamination of ultrasound-guided venipuncture
Time Frame: One hour after clinical decision of blood culture execution
Evaluation of blood sample bacterial contamination compared to blind puncture
One hour after clinical decision of blood culture execution

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Study Chair: Antonio M Dell'Anna, M.D., Fondazione Policlinico Universitario A. Gemelli, IRCCS

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 (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

December 3, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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