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

NCT04935905 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2022-01-26

No results posted yet for this study

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

Interventions

DEVICE

Mechanical Insufflator-Exsufflator

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

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Leyla Osman · Guy's and St Thomas' NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-04
Primary Completion
2021-09-01
Completion
2021-09-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04935905 on ClinicalTrials.gov