Pilot Study of Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Sufficient sputum quantity for a pellet
研究概览
简要总结
This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum.
Participants will use the Volara System during clinic visit in an attempt to produce sputum.
详细描述
Since the introduction of CFTR modulator therapies, most patients with Cystic Fibrosis (CF) have been unable to produce an adequate sputum sample for clinical monitoring. COVID-19 also presented a safety concern for staff and patients that may become exposed during sputum induction performed in the clinic rooms due to lack of negative pressure rooms and especially for patients who were unvaccinated. These issues led to lack of microbiology data for clinical care.
The purpose of this project is to identify a superior sputum collection method for those patients unable to produce a sputum to guide future antimicrobial management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
No parties will be prevented from having knowledge of the Volara System use.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •2. Currently prescribed hypertonic saline treatment as part of routine airway clearance therapy.
- •2. No sputum culture results in last one year or those who were unable to produce sputum from VPEP method used in QI project 3771
排除标准
- •< 18 years old
- •Sputum culture results in last one year
研究组 & 干预措施
Intrapulmonary Percussive Ventilation for Non-sputum Producer
Unable to produce adequate amount of lower airway bacterial sampling for culture results in last year.
干预措施: Volara System (Device)
结局指标
主要结局
Sufficient sputum quantity for a pellet
时间窗: 10 minutes
Percentage of patients with a successful culture result from sputum
Sufficient Sputum Quantity for a Pellet
时间窗: 10 minutes
Percentage of patients with a successful culture result from sputum
次要结局
未报告次要终点
研究者
Daniel J. Weiner
Professor of Pediatrics and Pediatric Pulmonologist
University of Pittsburgh