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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06156072
Collaborator
(none)
100
Enrollment
23.8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasound-guided venipuncture

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Use of Ultrasound for Blood Sample Drawing for Microbiological Analysis in Critically Ill Patients:he ECOVEN Feasibility Study
Anticipated Study Start Date :
Jan 7, 2024
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Number of attempted venipunctures [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

Secondary Outcome Measures

  1. Incidence of possible complications (accidental arterial puncture, visible ematoma) [One hour after clinical decision of blood culture execution]

    Evaluation of safety of venipuncture in terms of possible complications (accidental arterial puncture, ematoma)

  2. Incidence of contamination of ultrasound-guided venipuncture [One hour after clinical decision of blood culture execution]

    Evaluation of blood sample bacterial contamination compared to blind puncture

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
LA BELLA MARIACARMEN, Nurse, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT06156072
Other Study ID Numbers:
  • 6046
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Dec 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Shock, Septic
Critical Illness

Study Results

No Results Posted as of Dec 5, 2023