Diagnosis of ECMO Cannula Infection: Prospective Comparison of Sampling Methods
Condition(s) studied
Study summary
Extracorporeal membrane oxygenation (ECMO) is increasingly used as rescue support in patients with refractory respiratory and/or circulatory failure. ECMO cannula site infection (ECMO-CSI) complicates approximately 10% of ECMO runs and is associated with septic shock, prolonged intensive care unit (ICU) stay and increased mortality. To date, there is neither a standardized definition nor consensus diagnostic criteria for ECMO-CSI, and the optimal microbiological sampling strategy, as well as the diagnostic accuracy of the available methods, remains undetermined.
This single-center, prospective, non-interventional study aims to compare the diagnostic accuracy of three microbiological sampling methods (superficial swab of the cannula insertion site, needle aspiration along the cannula tract, and cannula tip culture) for the diagnosis of ECMO-CSI in adult patients receiving veno-venous or veno-arterial ECMO.
A superficial swab and a needle aspirate will be obtained at each cannulation site on the day ECMO-CSI is clinically suspected and on the day of decannulation. In addition, the tip of each cannula will be cultured at decannulation. The results of these index tests will be compared with a reference diagnosis of ECMO-CSI established by an adjudication committee of expert clinicians blinded to the index test results.
A total of 500 patients will be enrolled in order to obtain at least 50 patients with adjudicated ECMO-CSI.
Eligibility
Primary outcome measure(s)
- Diagnostic performance of each sampling strategy (superficial swab, needle aspiration, cannula tip culture) for the diagnosis of ECMO cannula infection — On the day of clinical suspicion of cannula infection and on the day of decannulation, up to ICU discharge (maximum 2 months)
Sensitivity, specificity, positive and negative predictive values of each sampling strategy, and its agreement with the reference diagnosis of cannula infection established by the adjudication committee.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hôpital Pitié Salpêtrière, Service de médecine intensive et réanimation | Paris | France |
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07893639 on ClinicalTrials.gov ↗ ← All trials in France