Accuracy of Peak Cough Flow Measurements Using a Mechanical Insufflator-exsufflator

NCT04935905 | Completed

• 1 other identifier: 272851
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to evaluate the agreement of MIE devices measurement of MIE assisted peak cough flow (PCF) compared with a pneumotachographs during usual MIE care. This will be the first study to do this through range of MIE pressures and include patients who are receiving MIE via a tracheostomy. It will also aim to evaluate the intra-subject repeatability of measures for patients who receive more than one MIE cycle as part of their usual care. It will be the first to measure MIE assisted PCF contemporaneously during intervention using the gold standard pneumotachograph. This will inform treatment effect size and the efficacy of usual practice MIE in augmenting PCF measurements above critical cut off values for effective cough and secretion clearance. Finally the study will also aim to understand how patients perceive the impact of MIE in clearing secretions from their chest by asking them to rate presence of chest secretions pre and post intervention using a visual analogue scale (VAS)

Conditions

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (1)

• Agreement of Peak Cough Flow between MIE and pneumotachograph.

  Peak Cough Flow measure the peak flow of expired air during the exsufflation phase of cough or MIE assisted cough

  Data will be collected at the point of recruitment to the study and then be reported within 1 year

Secondary Outcomes (5)

• Visual Analogue Scale

  Data will be collected at the point of recruitment to the study and then be reported within 1 year

• Treatment effect size of PCF during usual MIE care

  Data will be collected at the point of recruitment to the study and then be reported within 1 year

• Exploratory analysis of MIE Pressure and PCF

  Data will be collected at the point of recruitment to the study and then be reported within 1 year

• Exploratory analysis of MIE inspiratory Volume and PCF

  Data will be collected at the point of recruitment to the study and then be reported within 1 year

• Intra-subject variance of repeated PCF measures

  Data will be collected at the point of recruitment to the study and then be reported within 1 year

Interventions

Mechanical Insufflator-Exsufflator DEVICE

This device augments a cough by applying a positive pressure via the upper airway or tracheostomy to increase lung volume to maximal inspiratory capacity, followed by a rapid and quick change to negative pressure to increase expiratory flow and simulate normal cough mechanism

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with neuromuscular related respiratory failure and receiving MIE as part of their usual care

You may qualify if:

• Patients with neuromuscular disease-related respiratory failure and are receiving MIE as part of their usual care
• Patients who are clinical stable and documented as such by the supervising clinician
• Patients who are cognitively intact and have the capacity able to provide informed consent

You may not qualify if:

• Pregnancy
• Aged \<18
• Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St. Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Leyla Osman

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: June 23, 2021
• Study Start: December 4, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

GB (1)