Impact of High-Flow Tracheal Therapy on the Rheological Properties of Tracheobronchial Secretions in Tracheostomized Patients: A Randomized Crossover Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Critical stress (σc)
研究概览
简要总结
This monocentric, randomized crossover study aims to assess the impact of high-flow tracheal therapy (HFT) on the rheological properties of tracheobronchopulmonary secretions in tracheostomized patients. The primary objective is to compare the viscoelastic characteristics of secretions collected with and without HFT. Secondary objectives include evaluating the effects of HFT on dyspnea, patient comfort, and secretion appearance. The study will take place at Cliniques Universitaires Saint-Luc, with adult tracheostomized patients undergoing standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Adult patients (≥18 years old)
- •Tracheostomized patients
- •Patients requiring routine tracheal suctioning and already using HFT overnight
排除标准
- •Insufficient secretions for analysis
- •Cognitive impairment or confusion
研究组 & 干预措施
Control
HFT
干预措施: High-Flow Tracheal Therapy (Device)
结局指标
主要结局
Critical stress (σc)
时间窗: Measured three times: at baseline, after one hour, after 4 hours
The rheological properties measured using Rheomuco (Rheonova) will be sampled during a suctioning procedure. The critical stress σc = G\*(γc).γc, where G\*(γc) is the viscoelastic modulus measured at the critical strain, is the measured stress at which this transition occurs. See the description of the other rheological outcomes in the secondary outcomes.
次要结局
- Dyspnea (modified Borg scale)(Measured two times: at baseline and after 4 hours)
- Patient Comfort (Visual Analog Scale - VAS)(Measured two times: at baseline and after 4 hours)
- Secretion Appearance (Murray Scale)(Measured two times: at baseline and after 4 hours)
- Viscoelastic modulus (G*)(Measured three times: at baseline, after one hour, after 4 hours)
- Damping ratio (tan δ)(Measured three times: at baseline, after one hour, after 4 hours)
- Critical strain (γc)(Measured three times: at baseline, after one hour, after 4 hours)
研究者
William Poncin, PT, PhD
Principal Investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain