跳至主要内容
临床试验/NCT06201130
NCT06201130招募中不适用

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

Northwell Health1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Shannon diversity index

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Shannon diversity index

时间窗: December 2023-June 2025

A measure of alpha diversity

Bray-curtis dissimilarity

时间窗: December 2023-June 2025

A measure of beta diversity

Differential abundance

时间窗: December 2023-June 2025

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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