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临床试验/NCT05189600
NCT05189600招募中不适用

Can Waveform and Flow Traces From Mechanical Insuflattion:Exsufflation (MI:E) be Used to Identify Laryngeal Responses to MI:E and Thus Optimise Treatment Algorithms?

Royal Free Hospital NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
E70 (Mechnical insufflation:exsufflation) waveforms from Care Orchestrator

研究概览

简要总结

Objectives:

  • To establish if physiotherapists can use the waveform traces from the cough assist machine to work out when patients are having an abnormal airway response to cough assist
  • To establish how cough assist device settings, particularly in breath and cough pressures affect a patient's response to using the cough assist device
  • To provide some clinical guidance to physiotherapists on methods for assessing and treating abnormal airway responses to cough assist devices

Methodology:

Subjects will complete breathing tests; spirometry, peak cough flow (PCF) and sniff nasal inspiratory pressure (SNIP) to establish baseline breathing function and rule out anyone with breathing conditions. A nasal camera will be used to look at the voice box at rest.

Cough assist will be delivered via a face mask which will allow for simultaneous use of the nasal camera and cough assist carried out in the same way as another research team have done previously. The nasal camera will be attached to a video camera to allow recording, analysis and documentation of the observations. The cough assist protocol will be delivered by a physiotherapist experienced in delivering cough assist. Cough assist waveforms will be downloaded into Care Orchestrator software (Philips Respironics, Murraysville, USA) and reviewed at the same time as the nose camera recordings to establish if voice box responses can be identified from the waveform patterns. For confirmation of Care Orchestrator software waveforms, a device that records airflow during breathing (spirometer) will be connected (Alpha touch, Vitalograph, Ennis, Ireland) into the cough assist circuit in the same way another research team has before.

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
All
接受健康志愿者

入选标准

  • Patients with neuromuscular disease(NMD) including but not limited to Motor Neurone Disease (MND), Multiple Sclerosis (MS) and Muscular Dystrophy

排除标准

  • Unable to comply with protocol
  • Unable to give informed consent
  • Evidence of obstructive airways disease FEV1:FVC <0.7
  • Patients with a history of:
  • Un-drained pneumothorax
  • Severe bronchospasm
  • Head injury with ICP > 25mmHg
  • Severe arterial hypotension
  • Trache-oesophageal fistula
  • Significant haemoptysis
  • Facial fractures
  • Flail segment
  • Epistaxis within two weeks

结局指标

主要结局

E70 (Mechnical insufflation:exsufflation) waveforms from Care Orchestrator

时间窗: duration of study, approx. 30minutes per patient

E70 (Mechnical insufflation:exsufflation) waveforms from Care Orchestrator

Nasal endoscopy video recordings.

时间窗: duration of study, approx. 30minutes per patient

Nasal endoscopy video recordings.waveforms.

次要结局

未报告次要终点

研究者

发起方
Royal Free Hospital NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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