Skip to content

Airway Microbiome Changes After Artificial Airway Exchange in Critically-ill Pediatric Patients.

Airway Microbiome Changes After Artificial Airway Exchange in Critically-ill Pediatric Patients.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06201130
Enrollment
50
Registered
2024-01-11
Start date
2023-12-20
Completion date
2025-06-26
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Tube, Microbial Colonization, Pediatric Infectious Disease, Pediatrics, Tracheitis, Tracheostomy, Ventilator Associated Pneumonia

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.

Interventions

DIAGNOSTIC_TESTSuctioning 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.

Sponsors

Northwell Health
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Shannon diversity indexDecember 2023-June 2025A measure of alpha diversity
Bray-curtis dissimilarityDecember 2023-June 2025A measure of beta diversity
Differential abundanceDecember 2023-June 2025

Countries

United States

Contacts

Primary ContactEvin S Feldman, MD
efeldman4@northwell.edu(516) 562-3467
Backup ContactMariana R Brewer, MD
mbrewer@northwell.edu(516) 562-3467

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026