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

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201130
• Other study ID #: IRB-23-0420
• Status: Recruiting
• Start date: December 20, 2023
• Est. completion date: June 26, 2025

Study information

• Verified date: January 2024
• Source: Northwell Health
• Contact: Evin S Feldman, MD
• Phone: (516) 562-3467
• Email: efeldman4[@]northwell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 26, 2025
• Est. primary completion date: June 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Endotracheal Tube
• Infections
• Microbial Colonization
• Pediatric Infectious Disease
• Pediatrics
• Pneumonia, Ventilator-Associated
• Tracheitis
• Tracheostomy
• Ventilator Associated Pneumonia

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Cohen Children's Medical Center	Queens	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (6)

Kuhl LP, Marostica PJC, Macedo AJ, Kuhl G, Siebert M, Manica D, Sekine L, Schweiger C. High microbiome variability in pediatric tracheostomy cannulas in patients with similar clinical characteristics. Braz J Otorhinolaryngol. 2023 Mar-Apr;89(2):254-263. doi: 10.1016/j.bjorl.2022.05.001. Epub 2022 May 20. — View Citation

Maffei D, Brewer M, Codipilly C, Weinberger B, Schanler RJ. Early oral colostrum administration in preterm infants. J Perinatol. 2020 Feb;40(2):284-287. doi: 10.1038/s41372-019-0556-x. Epub 2019 Nov 20. — View Citation

Mitchell RB, Hussey HM, Setzen G, Jacobs IN, Nussenbaum B, Dawson C, Brown CA 3rd, Brandt C, Deakins K, Hartnick C, Merati A. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013 Jan;148(1):6-20. doi: 10.1177/0194599812460376. Epub 2012 Sep 18. — View Citation

Perez-Losada M, Graham RJ, Coquillette M, Jafarey A, Castro-Nallar E, Aira M, Freishtat RJ, Mansbach JM. The temporal dynamics of the tracheal microbiome in tracheostomised patients with and without lower respiratory infections. PLoS One. 2017 Aug 10;12(8):e0182520. doi: 10.1371/journal.pone.0182520. eCollection 2017. — View Citation

Perez-Losada M, Graham RJ, Coquillette M, Jafarey A, Castro-Nallar E, Aira M, Hoptay C, Freishtat RJ, Mansbach JM. Tracheal Microbiota in Patients With a Tracheostomy Before, During and After an Acute Respiratory Infection. Pediatr Infect Dis J. 2018 Nov;37(11):e269-e271. doi: 10.1097/INF.0000000000001952. — View Citation

Zachariah P, Ryan C, Nadimpalli S, Coscia G, Kolb M, Smith H, Foca M, Saiman L, Planet PJ. Culture-Independent Analysis of Pediatric Bronchoalveolar Lavage Specimens. Ann Am Thorac Soc. 2018 Sep;15(9):1047-1056. doi: 10.1513/AnnalsATS.201802-146OC. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shannon diversity index	A measure of alpha diversity	December 2023-June 2025
Primary	Bray-curtis dissimilarity	A measure of beta diversity	December 2023-June 2025
Primary	Differential abundance		December 2023-June 2025