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临床试验/NCT02566512
NCT02566512已完成不适用

Assessment of Cough Strength in Patients With Tracheostomies

University of Manitoba2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Peak expiratory flow rate

研究概览

简要总结

The investigators propose to assess cough strength in patients undergoing spontaneous breathing trials in the Intermediate Intensive Care Unit (IICU) and compare their cough strength under two conditions,

  1. Tracheostomy cuff inflated: cough strength will be measured with the tracheostomy cuff inflated and the patient coughing through the tracheostomy tube.
  2. Tracheostomy cuff deflated: cough strength will be measured with the tracheostomy cuff deflated and the patient coughing around the tracheostomy tube, through their mouth..

The investigators hypothesize that patients will have a stronger cough when they can use their vocal cords.

详细描述

When a patient has recovered from the initial respiratory insult which precipitated respiratory failure, the patient may need a prolonged period of time to wean completely from mechanical ventilation.

One method of weaning from mechanical ventilation involves having the patient breath spontaneously without the assistance of the ventilator. This is referred to as a spontaneous breathing trial. Over time, the duration of spontaneous breathing is gradually increased until the patient is able to breathe entirely on their own. Traditionally, the tracheostomy cuff has been kept inflated until the patient can breathe entirely on their own (2,3).

A recent study has assessed the effect of deflating the tracheostomy tube cuff on weaning from mechanical ventilation (4). Patients, who required prolonged mechanical ventilation and had a tracheostomy, were weaned using a T piece trial. They were randomized to two groups: the control group had the tracheostomy cuff kept inflated; the study group had the tracheostomy cuff deflated. The study group, with the cuff deflated, had a shorter time to weaning from the ventilator, fewer respiratory infections and improved swallowing. This was attributed to an increase in the effective airway diameter, which would decrease the resistive work of breathing. The authors did not comment on the effect cuff deflation may have on coughing and clearance of secretions.

It is postulated that patients can cough more effectively when he/she can use their vocal cords to generate a cough as opposed to coughing through a tracheostomy tube where the vocal cords are bypassed. It has been previously demonstrated that patients have a stronger cough after the tracheostomy tube has been removed as compared to when the tracheostomy tube is in place (5).

Patient population

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The study group will include all adult patients in the IICU, on prolonged mechanical ventilation who are having spontaneous breathing trials as part of their weaning protocol.

排除标准

  • Any patient who has a leak around their tracheostomy tube when the tracheostomy cuff is inflated.
  • Inability to understand English or cognitive impairment which impairs the patient's ability to follow directions.

研究组 & 干预措施

Tracheostomy cuff inflated

Other

The tracheostomy cuff will be inflated.

干预措施: Tracheostomy cuff inflation. (Other)

Tracheostomy cuff deflated

Other

The tracheostomy cuff will be deflated.

干预措施: Tracheostomy cuff deflation (Other)

结局指标

主要结局

Peak expiratory flow rate

时间窗: Twenty minutes

peak flow rate during a cough

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 (2)

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