Recruiting

Observational Study

Sponsor:

Northwell Health

Code:

NCT06201130

Conditions

Tracheostomy

Endotracheal Tube

Ventilator Associated Pneumonia

Tracheitis

Microbial Colonization

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Suctioning of artificial airway

Study Details

Brief summary:

Artificial airways, such as endotracheal tubes and tracheostomies, in the pediatric and neonatal intensive care units (PICU, NICU respectively) are lifesaving for patients in respiratory failure, among other conditions. These devices are not without a risk of infection - ventilator-associated infections (VAIs), namely ventilator associated pneumonia (VAP) and ventilator-associated tracheitis (VAT), are common. Treatment of suspected VAI accounts for nearly half of all Pediatric Intensive Care Unit (PICU) antibiotic use. VAI can represent a continuum from tracheal colonization, progression to tracheobronchial inflammation, and then pneumonia. Colonization of these airways is common and bacterial growth does not necessarily indicate a clinically significant infection. Tracheostomies, which are artificial airways meant for chronic use, are routinely exchanged on a semi-monthly to monthly basis, in part to disrupt bacterial biofilm formation that aids bacterial colonization and perhaps infection. When patients with tracheostomies are admitted for acute on chronic respiratory failure or a concern for an infection, these artificial airways are also routinely exchanged at some institutions. There however remains a critical need to understand how an artificial airway exchange alters the bacterial environment of these patients in sickness and in health. This research hypothesizes that exchanging an artificial airway will alter the microbiome of the artificial airway, by altering the microbial diversity and relative abundance of different bacterial species of the artificial airway. This study will involve the prospective collection of tracheal aspirates from patients with artificial airways. We will screen and enroll all patients admitted to a the NICU or PICU at Cohen Children's Medical Center (CCMC) who have tracheostomies and obtain tracheal aspirates within 72 hours before and after tracheostomy or endotracheal tube exchange. Tracheal aspirates are routinely obtained in the NICU and PICU from suctioning of an artificial airway and is a minimal risk activity. These samples will be brought to the Feinstein Institutes for Medical Research for 16 s ribosomal DNA (16srDNA) sequencing, which allows for accurate and sensitive detection of relative abundance and classification of bacterial flora. Tracheal aspirate sets will be analyzed against each other. Additionally, clinical and epidemiological data from the electronic medical record will be obtained. Antibiotic exposure will be accounted for via previously published means.

Conditions

Tracheostomy

Endotracheal Tube

Ventilator Associated Pneumonia

Tracheitis

Microbial Colonization

Study ID

NCT06201130

Start date

Dec 20, 2023

Status verified date

Jan, 2024

Completion date

Jun 26, 2025

Anticipated

Primary completion date

Jun 26, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients with tracheostomies in the pediatric or neonatal intensive care unit
  • Patients with endotracheal tubes undergoing artificial airway exchange in the pediatric or neonatal intensive care unit

Exclusion Criteria:

  • None

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

Suctioning of artificial airway

Collection of tracheal aspirates in either the PICU or NICU will occur. We will instill 1 mL of normal saline, then perform bag ventilation, and then suction out aspirate. Suctioning is routinely performed for tracheostomy and endotracheal tube hygiene - for instance, it is performed on tracheostomies by caregivers at home. The aspirates that will be collected will be clinically indicated and otherwise would be discarded. If the patients weren't enrolled in this research, the aspirates would have been collected anyways.

Primary outcome measure

  • Shannon diversity index [ Time Frame: December 2023-June 2025 ]
  • Bray-curtis dissimilarity [ Time Frame: December 2023-June 2025 ]
  • Differential abundance [ Time Frame: December 2023-June 2025 ]

Central Contacts and Locations

Central contacts

Locations

Cohen Children's Medical Center

Recruiting

Queens, New York, United States, 11040

Contacts

More Information

Sponsor

Northwell Health

Last update posted

Jan 17, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2024-01-17.