Subglottic Secretion Culture in Predicting Tracheal Microbial Flora

NCT03153241 | Completed

• 1 other identifier: 001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Ventilator-associated pneumonia (VAP) continues to be a major cause of morbidity and mortality in the intensive care unit (ICU). Microaspiration of subglottic secretions accumulated above the endotracheal tube cuff is the primary route of bacterial entry into the lower respiratory tract.Therefore, removal of secretions from the subglottic spacehas been recommended as a preventive strategy to avoid microaspiration and VAP. In this context, whereas considerable literature exists on the use subglottic secretion drainage (SSD) in patients at risk for developing VAP, there is a lack of data on the bacterial growth in the subglottic fluid above the cuff. The primary objective of the study will be to assess the value of subglottic secretion culture in predicting microbial flora of endotracheal aspirate samplein patients admitted to our ICU and under invasive mechanical ventilation for at least 48 hours. Secondary end-point will be to estimate the predictive value of subglottic secretion culture in identifying bacterial pathogens in the sub-population of patients who will develop VAP.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• Number of patients with the same pathogens in both subglottic secretions and endotracheal aspirates

  6 months

Interventions

No intervention OTHER

No intervention

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

ICU patients under invasive mechanica ventilations for at least 48 hours

You may qualify if:

• ≥18 years of age
• Invasive mechanical ventilation for at least 48 hours

You may not qualify if:

• age \<18 years
• absence of informed consent
• pregnancy
• documented treatment-limitation orders in the patient's chart

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazioen Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

Related Publications (1)

• Bello G, Bisanti A, Giammatteo V, Montini L, Eleuteri D, Fiori B, La Sorda M, Spanu T, Grieco DL, Pennisi MA, De Pascale G, Antonelli M. Microbiologic surveillance through subglottic secretion cultures during invasive mechanical ventilation: a prospective observational study. J Crit Care. 2020 Oct;59:42-48. doi: 10.1016/j.jcrc.2020.05.013. Epub 2020 May 26.

  PMID: 32516641 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

subglottic secretions and tracheal aspirates

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Giuseppe Bello (Principal-Investigator)

Study Record Dates

• First Submitted: April 29, 2017
• First Posted: May 15, 2017
• Study Start: October 20, 2017
• Primary Completion: October 20, 2018
• Study Completion: November 20, 2018
• Last Updated: September 25, 2024

Record last verified: 2019-07

Locations

IT (1)