Safe Use of Speaking Valve in Children During Sleep Using Trans-tracheal Pressure Measurement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 主要终点
- Trans-tracheal Pressure Measurement
研究概览
简要总结
Many children who are born medically fragile due to prematurity, multiple congenital abnormalities or an acquired insult (i.e. cardiac, neurologic, etc.) may require tracheostomy tube placement due to need of chronic respiratory support. Patients on tracheostomy tubes are often unable to vocalize, causing a delay in speech development and poor speech. To help restore normal phonation and promote language development in young pediatric patients with tracheostomies, speaking valves are used. Previously it was shown that the Passy-Muir speaking valve was safe to use during sleep in children by showing there were no adverse cardiopulmonary events seen. One objective measurement that was not evaluated was trans-tracheal pressure manometry. The purpose of this study is to continue to validate the safety of the Passy-Muir speaking valve while asleep, with the use of trans-tracheal manometry by comparing expiratory pressure manometry while the patient is awake and asleep.
详细描述
Previously it was shown that the Passy-Muir speaking valve was safe to use during sleep in children. There were no adverse cardiopulmonary events seen while wearing the speaking valve during sleep. However, trans-tracheal pressure was not measured while these children were asleep wearing the Passy-Muir speaking valve.The investigators hypothesize that patients who tolerate speaking valve while awake will have similar trans-tracheal pressure measurement when asleep as when they are awake.
The specific aims of this proposal are:
- to show that the Passy-Muir speaking valve worn during sleep has similar trans-tracheal pressure manometry as when worn while awake.
The primary outcome measure is to show that trans-tracheal manometry measurement is similar while on the Passy-Muir speaking valve when patients are awake and asleep
Secondary outcomes are a) recording of symptoms (i.e. choking, gagging, increased respiratory rate, abnormal breathing pattern, coughing, chest tightness and aversion) while wearing the speaking valve either awake or asleep b) recording vital signs which will be compared to normal and baseline for age (i.e. heart rate, respiratory rate, end-tidal carbon dioxide and oxygen saturation) while awake and asleep.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Any subject between the ages of 0-18 years of age who is a resident of St Mary's Healthcare System for Children with a chronic tracheostomy may be enrolled. Patients have to be approved for a Passy-Muir speaking valve as per St Mary's Healthcare System for Children written policy.
排除标准
- •i. Patients who do not meet the criteria for the use of speaking valve (i.e. unconscious and/or comatose patients, patients who require 24-hour inflated tracheostomy tube cuff due to inadequate ventilation, foam-filled tracheostomy tube, severe airway obstruction, unmanageable thick secretions, severe risk for aspiration, severely reduced lung elasticity, and not intended for use with endotracheal tubes).
- •ii. Patients with an acute illness and is not at baseline status. iii. Have any kind of respiratory distress.
结局指标
主要结局
Trans-tracheal Pressure Measurement
时间窗: one day
trans-tracheal manometry measurement is similar while on the Passy-Muir speaking valve when patients are awake and asleep
次要结局
- vital signs(one day)
- Recording of symptoms(one day)