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?

Neuromuscular Diseases Clinical Trial

— SETTLE  

Official title:

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05189600
• Other study ID #: 140484
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2024
• Source: Royal Free Hospital NHS Foundation Trust
• Contact: Stephanie Mansell
• Phone: 0207 794 0500
• Email: stephanie.mansell1[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Age =18

Exclusion Criteria:

• 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

• Vomiting

• Flail segment

• Epistaxis within two weeks

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Device:
• Mechnical Insufflation:Exsufflation
Cough Augmentation device

Locations

Country	Name	City	State
United Kingdom	Royal Free London NHS foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Free Hospital NHS Foundation Trust	Private Physiotherapy Education Fund

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	E70 (Mechnical insufflation:exsufflation) waveforms from Care Orchestrator	E70 (Mechnical insufflation:exsufflation) waveforms from Care Orchestrator	duration of study, approx. 30minutes per patient
Primary	Nasal endoscopy video recordings.	Nasal endoscopy video recordings.waveforms.	duration of study, approx. 30minutes per patient