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OpenTrials
Completed

NCT Number: NCT03153241

Subglottic Secretion Culture in Predicting Tracheal Microbial Flora

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazioen Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Value of Subglottic Secretion Culture in Predicting Microbial Flora of Tracheal Secretions in Intubated Patients. a Prospective Observational Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 15, 2017
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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