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

NCT06156072 | Not Yet Recruiting

• 1 other identifier: 6046
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Sepsis; Septic Shock; Infections; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of possible complications (accidental arterial puncture, visible ematoma)

  One hour after clinical decision of blood culture execution

• Incidence of contamination of ultrasound-guided venipuncture

  One hour after clinical decision of blood culture execution

Study Arms (1)

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

Interventions

Ultrasound-guided venipuncture DIAGNOSTIC_TEST

Venipuncture will be performed using ultrasound to identify the most appropriate vessel and guide the puncture

Patient requiring blood culture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Sepsis; Shock, Septic; Infections; Disease

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Antonio M Dell'Anna, M.D.

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  STUDY CHAIR

Central Study Contacts

Antonio M Dell'Anna, M.D.

CONTACT

3803679256; antoniomaria.dellanna@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 5, 2023
• Study Start: June 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-02