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NCT06156072 Clinical Trial

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

Sepsis Clinical Trial

— ECOVEN  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06156072
Other study ID # 6046
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date December 31, 2025

Study information
Verified date February 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Antonio M Dell'Anna, M.D.
Phone 3803679256
Email antoniomaria.dellanna@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Ultrasound-guided venipuncture
Venipuncture will be performed using ultrasound to identify the most appropriate vessel and guide the puncture

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome
Type Measure Description Time frame Safety issue
Primary Number of attempted venipunctures 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 Incidence of possible complications (accidental arterial puncture, visible ematoma) Evaluation of safety of venipuncture in terms of possible complications (accidental arterial puncture, ematoma) One hour after clinical decision of blood culture execution
Secondary Incidence of contamination of ultrasound-guided venipuncture Evaluation of blood sample bacterial contamination compared to blind puncture One hour after clinical decision of blood culture execution
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