Comparison between face masks and mouthpieces: effects on measurement of cough strength and use of a cough assist machine

Not Applicable

Recruiting

• Conditions: Neuromuscular disease; Neurological - Other neurological disorders; Respiratory muscle weakness; Respiratory - Other respiratory disorders / diseases; Neurological - Neurodegenerative diseases

• Registration Number: ACTRN12624000199516
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-29
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Stage 1 and Stage 2 of the study:
-Medically stable individuals with suspected or known respiratory muscle weakness who are
greater than or equal to 18 years of age
- Able to provide informed consent and willing to participate and comply with the study requirements

Additional criteria for Stage 2 of the study:
- Free from contraindications to forced manoeuvres or positive pressure ventilation

Exclusion Criteria

Stage 1
- Inability to follow instructions
- Inability to understand written or verbal English
- Inability to obtain a seal lip with a mouthpiece
- Pain or other conditions that may impede cough
- Tracheostomy
- Standard contraindications to forced respiratory manoeuvres

Stage 2
- Standard contraindications to positive pressure therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stage 1: Unassisted peak cough flow (L/min) with the oronasal mask compared to the mouthpiece interface<br>[Stage 1: Mini Wright peak flow meter attached to each interface<br> Stage 1: All measures will be completed during a single visit . Unassisted peak cough flow will be recorded on the data collection form immediately after each manoeuvre is performed. <br>];Stage 2: Peak cough flow (L/min) during mechanical in-exsufflation with the oronasal mask compared to the mouthpiece interface[Stage 2: The mechanical in-exsufflation machine will measure and display peak cough flow real-time for each interface<br> Stage 2: All measures will be completed in a single visit (this may be the same visit as Stage 1). Peak cough flow measured using the mechanical in-exsufflation device will be recorded on the data collection form immediately after each manoeuvre is performed.<br> <br>]