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NCT03153241 Clinical Trial

Subglottic Secretion Culture in Predicting Tracheal Microbial Flora

Pneumonia Clinical Trial

Official title:
Value of Subglottic Secretion Culture in Predicting Microbial Flora of Tracheal Secretions in Intubated Patients. A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03153241
Other study ID # 001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 20, 2017
Est. completion date November 20, 2018

Study information
Verified date July 2019
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 20, 2018
Est. primary completion date October 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- =18 years of age

- Invasive mechanical ventilation for at least 48 hours

Exclusion Criteria:

- age <18 years

- absence of informed consent

- pregnancy

- documented treatment-limitation orders in the patient's chart

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
Italy Fondazioen Policlinico Universitario A. Gemelli IRCCS Roma

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

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with the same pathogens in both subglottic secretions and endotracheal aspirates 6 months
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