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Changes in Regional Lung Ventilation Following Mechanical Insufflation-Exsufflation

NCT02753959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-02-10

No results posted yet for this study

Summary

Patients with NMD can suffer from a range of respiratory problems due to respiratory muscle weakness. Cough muscle weakness worsens secretion clearance from the airways, and increases the risk of infection. As a result, these patients often require chest physiotherapy or are supported with devices to aid clearance (such as mechanical insufflation-exsufflation) to reduce the risk of infection. Although evidence supports the use of these devices, the optimal technique or settings on the device are not clear.

Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of sensors around the chest that provides information on how well the lungs are being filled with air. It allows a non-invasive assessment of the effect of each secretion clearance technique on lung ventilation in real-time.

This study aims to compare how well the lung is filled with air between three different techniques for secretion clearance (clearing mucus and phlegm from the airways), in order to determine which of the techniques is the most effective, in patients with NMD.

Conditions

Interventions

OTHER

Acute Intervention

Patients will be set up onto their Non Invasive Ventilator and assessed for an hour prior to, during and following secretion clearance and will have the following assessed: * Electrical impedance tomography (EIT) * EMGpara * SpO2 * tcCO2 * Respiratory inductance plethysmography * EIT will be performed as 2 to 10-minutes recording of quiet breathing before and after each intervention Interventions will be set as follows with a 30 minute washout period between modes: * Manual techniques only * MIE at low pressure (+30 to -30) * MIE at high pressure (+60 to -60)

OTHER

Stable Intervention

Patients will be set up onto their Non Invasive Ventilator and assessed for an hour prior to, during and following secretion clearance and will have the following assessed: * Electrical impedance tomography (EIT) * EMGpara * SpO2 * tcCO2 * Respiratory inductance plethysmography * EIT will be performed as 2 to 10-minutes recording of quiet breathing before and after each intervention Interventions will be set as follows with a 30 minute washout period between modes: * Manual techniques only * MIE at low pressure (+30 to -30) * MIE at high pressure (+60 to -60)

Sponsors & Collaborators

  • B&D Electromedical

    collaborator INDUSTRY

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2019-09-30
Completion
2019-09-30

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 NCT02753959 on ClinicalTrials.gov