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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?

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?

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05189600
Acronym
SETTLE
Enrollment
20
Registered
2022-01-12
Start date
2022-01-01
Completion date
2025-01-01
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Diseases

Brief 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.

Interventions

DEVICEMechnical Insufflation:Exsufflation

Cough Augmentation device

Sponsors

Private Physiotherapy Education Fund
CollaboratorUNKNOWN
Royal Free Hospital NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
E70 (Mechnical insufflation:exsufflation) waveforms from Care Orchestratorduration of study, approx. 30minutes per patientE70 (Mechnical insufflation:exsufflation) waveforms from Care Orchestrator
Nasal endoscopy video recordings.duration of study, approx. 30minutes per patientNasal endoscopy video recordings.waveforms.

Countries

United Kingdom

Contacts

Primary ContactStephanie Mansell
stephanie.mansell1@nhs.net0207 794 0500
Backup ContactR&D Manager
rf.randd@nhs.net02077940500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026