Accuracy of Peak Cough Flow Measurements Using a Mechanical Insufflator-exsufflator in Patients With Neuromuscular Disease: A Single Centre Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Agreement of Peak Cough Flow between MIE and pneumotachograph.
研究概览
简要总结
The primary aim of this study is to evaluate the agreement of MIE devices measurement of MIE assisted peak cough flow (PCF) compared with a pneumotachographs during usual MIE care. This will be the first study to do this through range of MIE pressures and include patients who are receiving MIE via a tracheostomy. It will also aim to evaluate the intra-subject repeatability of measures for patients who receive more than one MIE cycle as part of their usual care. It will be the first to measure MIE assisted PCF contemporaneously during intervention using the gold standard pneumotachograph. This will inform treatment effect size and the efficacy of usual practice MIE in augmenting PCF measurements above critical cut off values for effective cough and secretion clearance.
Finally the study will also aim to understand how patients perceive the impact of MIE in clearing secretions from their chest by asking them to rate presence of chest secretions pre and post intervention using a visual analogue scale (VAS)
详细描述
Patients with a neuromuscular disease (NMD) lose strength in their breathing muscles which leads to an inability to generate an effective cough. Peak Cough Flow (PCF) is a simple objective measure of cough and is the recommended measure in patients with NMD. Critical peak cough flow values are used to evaluate cough, these include PCF less than 160 L/min to indicate an ineffective cough, PCF between 161- 270 to indicate an impaired cough and PCF greater than 270 L/min to indicate an effective cough. Mechanical insufflator- exsufflator (MIE) devices more commonly known as 'cough assist' devices have an inbuilt measure of PCF however they aren't currently recommended for use to due to limited information available regarding their accuracy. This will be a single centre prospective observational study. Once patients have consented to participate in the study, they will be visited once on the unit during their admission by the researcher with the visit lasting approximately an hour.
During the visit they will receive their usual care MIE with a pneumotachograph fitted into the circuit. The primary outcome is the agreement of MIE assisted PCF measures between the MIE device and pneumotachograph. Before and after the intervention the patient will be asked to rate the presence of mucous in their lungs using a visual analogue scale.
The following data will be recorded
- Neuromuscular diagnosis
- Age, height, weight,
- Comorbidities
- Hospital length of stay (Days)
- Ventilation dependency(hours/Day)
- Bronchodilator and/or mucolytic medications
- Vital observations (heart rate, blood pressure, oxygen saturations)
- Method of MIE delivery (mask or tracheostomy)
- Tracheostomy size, type and brand
- Bulbar function if available (Laryngoscope)
- Spirometry - Forced Expired Volume in 1 second (FEV1), Forced Vital Capacity (FVC), (from clinical notes)
- Voluntary PCF (collected from patient by researcher)
- MIE Mode (collected from device by researcher)
- MIE Total number cycle repeats (collected from device by researcher)
- MIE device Inspiratory pressure (collected from device by researcher)
- MIE inspiratory pressure at interface (Pressure transducer)
- MIE inspiratory time (collected from device by researcher)
- MIE peak inspiratory Flow (from device by researcher)
- MIE device expiratory pressure (collected from device by researcher)
- MIE expiratory pressure at interface (Pressure transducer)
- MIE Expiratory time (collected from device by researcher)
- MIE Assisted PCF Pneumotachograph (From patient by researcher)
- MIE Assisted PCF MIE (From patient by researcher)
- Visual Analogue Scale regarding secretion presence pre and post MIE (from patient by researcher)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with neuromuscular disease-related respiratory failure and are receiving MIE as part of their usual care
- •Patients who are clinical stable and documented as such by the supervising clinician
- •Patients who are cognitively intact and have the capacity able to provide informed consent
排除标准
- •Pregnancy
- •Aged <18
- •Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
结局指标
主要结局
Agreement of Peak Cough Flow between MIE and pneumotachograph.
时间窗: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Peak Cough Flow measure the peak flow of expired air during the exsufflation phase of cough or MIE assisted cough
次要结局
- Visual Analogue Scale(Data will be collected at the point of recruitment to the study and then be reported within 1 year)
- Treatment effect size of PCF during usual MIE care(Data will be collected at the point of recruitment to the study and then be reported within 1 year)
- Exploratory analysis of MIE Pressure and PCF(Data will be collected at the point of recruitment to the study and then be reported within 1 year)
- Intra-subject variance of repeated PCF measures(Data will be collected at the point of recruitment to the study and then be reported within 1 year)
- Exploratory analysis of MIE inspiratory Volume and PCF(Data will be collected at the point of recruitment to the study and then be reported within 1 year)