跳至主要内容
临床试验/NCT07061561
NCT07061561尚未招募不适用

Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)

Centre Hospitalier de Saint-Denis0 个研究点目标入组 34 人开始时间: 2025年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
34
主要终点
Predictive Value of Peak Expiratory Flow (PEF) Measured Before Decannulation for PEF After Decannulation in Tracheotomized Patients.

研究概览

简要总结

This study aims to evaluate how well tracheotomized patients can cough before and after their tracheostomy tube is removed. Cough strength is measured using two different tools-Peak Flow and Lorio. Researchers want to find out if the cough measurement taken before removing the tube can help predict how effective the patient's cough will be afterward. The study will also explore factors that might influence cough strength and compare the usefulness of the two tools. Additionally, it will assess how patients feel about using these devices and the role of diaphragm ultrasound in predicting cough effectiveness.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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 or older)
  • •Hospitalized in post-intensive care rehabilitation unit (SRPR) or intensive care unit (ICU)
  • •Tracheotomized during the weaning process
  • •Medical prescription for physiotherapy assessment
  • •Medical prescription for speech therapy assessment

排除标准

  • •Patients who have undergone total laryngectomy
  • •Patients with severe swallowing disorders
  • •Patients with cognitive impairments incompatible with understanding instructions
  • •Patients under medical decision to stop active treatments
  • •Patients who refuse to participate or refuse to sign informed consent
  • •Patients under guardianship or curatorship
  • •Patients not affiliated with a social security scheme

研究组 & 干预措施

Single Group - Cough Effort Measurement and Follow-Up

Other

干预措施: Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device (Device)

结局指标

主要结局

Predictive Value of Peak Expiratory Flow (PEF) Measured Before Decannulation for PEF After Decannulation in Tracheotomized Patients.

时间窗: From pre-decannulation measurement (up to 7 days before) to 72 hours after decannulation.

Predictive Value of Peak Expiratory Flow (PEF) Measured Before Decannulation for PEF After Decannulation in Tracheotomized Patients.

时间窗: From pre-decannulation measurement (up to 7 days before) to 72 hours after decannulation.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier de Saint-Denis
申办方类型
Other
责任方
Sponsor

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