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临床试验/NCT05873504
NCT05873504招募中不适用

Outcome Comparisons of Two Vibratory Positive Expiratory Pressure Devices in Patients Unable to Clear Airway Secretions

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
1
主要终点
Respiratory assess and treat (RAAT) score

研究概览

简要总结

This pilot study aims to compare the ability of a higher oscillatory index device versus a lower oscillatory index device on airway secretion clearance and other clinically significant outcomes.

详细描述

This pilot study is a randomized control trial of adult patients admitted to an academic medical center. Subjects included in this study must be adults 18 years or older and will receive a respiratory assessment and allocation of therapy (RAAT) score of at least 10 and a secretion score of at least 5. Exclusion criteria include those younger than 18 years of age, those who are pregnant, with an SVC of <10mL/kg, and who cannot follow instructions or currently receiving cough assist, vest or intrapulmonary percussive ventilation. Patients receiving more than one therapy session using the oscillatory index device before enrollment will be excluded. Patients with multiple ICU admissions will be enrolled once. Cluster randomization will be used, with device assignment alternating by month. The assigned device will be administered per unit protocol by bedside clinical staff. Each eligible patient will receive clinical evaluation using RAAT scores per the department policy. The frequency of using oscillatory index devices will be based on the department protocol. Each subject will be followed up until discharge from the hospital. The primary outcome will be the RAAT score. The RAAT score range from 0-50 and includes five components: respiratory rate, oxygen therapy, chest x-ray, secretion clearance, and vital capacity. The higher score denotes respiratory compromise, and therapy is assigned for score 10 or greater per departmental protocol. The secondary outcomes include respiratory interventions used or other bronchial hygiene (vest therapy, intrapulmonary percussive ventilation) performed, ICU re-admission, need for continuous positive pressure, and length of stay (hospital and ICU).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Adults 18 years or older
  • Respiratory assess and treat (RAAT) score of at least 10 and a secretion score of at least 5

排除标准

  • Younger than 18 years of age
  • Slow vital capacity (SVC) of <10 mL/kg
  • Unable to follow instructions
  • Currently receiving cough assist, vest therapy or intrapulmonary percussive ventilation
  • Received more than 1 therapy session using oscillatory index device
  • Multiple ICU admission with previous study enrollment

研究组 & 干预措施

High Oscillatory Index Device

Experimental

Patients in this arm will receive a device that vibrates with high oscillatory index.

干预措施: High Oscillatory Index Device (Device)

Low Oscillatory Index Device

Active Comparator

Patients in this arm will receive a device that vibrates with low oscillatory index.

干预措施: Low Oscillatory Index Device (Device)

结局指标

主要结局

Respiratory assess and treat (RAAT) score

时间窗: Change from baseline RAAT score at 12 hours

The RAAT score range from 0-50.

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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