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?

NCT05189600 | Recruiting DMC FDA Device

• 1 other identifier: 140484
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (2)

• E70 (Mechnical insufflation:exsufflation) waveforms from Care Orchestrator

  E70 (Mechnical insufflation:exsufflation) waveforms from Care Orchestrator

  duration of study, approx. 30minutes per patient

• Nasal endoscopy video recordings.

  Nasal endoscopy video recordings.waveforms.

  duration of study, approx. 30minutes per patient

Interventions

Mechnical Insufflation:Exsufflation DEVICE

Cough Augmentation device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with neuromuscular disease(NMD) including but not limited to Motor Neurone Disease (MND), Multiple Sclerosis (MS) and Muscular Dystrophy
• Age ≥18

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead
• Private Physiotherapy Education Fund: collaborator

Study Sites (1)

Royal Free London NHS foundation Trust

London, NW3 2QG, United Kingdom

RECRUITING

Related Publications (1)

• Mansell SK, Parry R, Shah A, Gowing F, Greenfield C, Bhatt Y, Mandal S. Pilot observational cohort study to determine whether waveform and flow traces from mechanical insufflation-exsufflation (MI-E) can be used to identify laryngeal responses to MI-E and thus optimise treatment algorithms in neuromuscular patients in a tertiary centre: a protocol description. BMJ Open Respir Res. 2024 Mar 9;11(1):e001599. doi: 10.1136/bmjresp-2022-001599.

  PMID: 38460974 DERIVED

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Stephanie Mansell

CONTACT

0207 794 0500; stephanie.mansell1@nhs.net

R&D Manager

CONTACT

02077940500; rf.randd@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: January 12, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)