跳至主要内容
临床试验/NCT01090804
NCT01090804Unknown2 期

The Effectiveness of BreatheMAX Breathing Device on Airway Secretion Clearance in Patients With Ventilatory Dependence

Khon Kaen University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
2 期
入组人数
14
试验地点
2
主要终点
secretion wet weight (gram)

研究概览

简要总结

The purpose of this study is to determined effects of BreatheMAX on secretion clearance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
15 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • One sign of secretion accumulation in bronchi
  • Stable cardiopulmonary function
  • Good consciousness and good co-operation

排除标准

  • Massive hemoptysis
  • Pneumothorax (untreated)

结局指标

主要结局

secretion wet weight (gram)

时间窗: Three hours before, ten hours after treatment and night-time (02.00-07.00 am.)

Airway mucus secretion was collected for three hours before and ten hours after treatment based on an auditory airway secretion sound and collected again at 02.00-07.00 am.The mucus secretion was collected by sterile suctioning technique via tracheostomy tube without adding any saline or sterile water.

viscosity of secretion

时间窗: Three hours before and after treatment

The secretion were collected in three hours before and after treatment, It were measured viscosity by First The mucus was gently homogenized by tissue grinder 5 ml (Cw11-205, Cowie, UK) for six minute at 37 degree celsius Second using Micro-Oswald viscometers with a capillary diameter of 0.77 mm for viscosity measure at same temperature in each sample(before and after).

次要结局

  • Oxygen saturation (%SpO2)(Before, during breathing exercise with device and immediate after treatment)
  • Heart rate (beat/min)(Before, during breathing exercise with device and immediate after treatment)
  • Respiratory rate (times/min)(In rest interval between set (1 minute))

研究者

申办方类型
Other

研究点 (2)

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