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? (SETTLE)

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Diseases
• Intervention / Treatment: Device: Mechnical Insufflation:Exsufflation

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Stephanie Mansell; Phone Number: 0207 794 0500; Email: stephanie.mansell1@nhs.net
• Study Contact Backup: Name: R&D Manager; Phone Number: 02077940500; Email: rf.randd@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, NW3 2QG
    • Recruiting
    • Royal Free London NHS Foundation Trust
    • Contact: Stephanie Mansell, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with neuromuscular disease

Description

Inclusion Criteria:

• Patients with neuromuscular disease(NMD)
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Royal Free Hospital NHS Foundation Trust
• Collaborators: Private Physiotherapy Education Fund

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: 140484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No