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

Not yet recruiting

• Conditions: Infections; Diagnosis; Sepsis; Septic Shock
• Interventions: Diagnostic Test: Ultrasound-guided venipuncture

• Registration Number: NCT06156072
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-12-03
• Study First Posted: 2023-12-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Study Start: 2025-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient requiring blood culture	Ultrasound-guided venipuncture	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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)