Changes in Regional Lung Ventilation Following Mechanical Insufflation-Exsufflation

NCT02753959 | Completed

• 1 other identifier: PM Mar 16
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (1)

• Reduction in the regional ventilation delays and Increase in homogeneity of ventilation post MIE vs baseline.

  1 day

Secondary Outcomes (3)

• Change in neural respiratory drive (EMGpara) pre to post clearance

  1 day

• Change in gas exchange (SpO2 and tcCO2)

  1 day

• Subjective patient comfort (Visual analogue scale - VAS)

  1 day

Study Arms (2)

Acute Intervention

EXPERIMENTAL

Patients will need to be Clinically stable patients with established neuromuscular disease with clinical secretions or cough PEF \<270 and history of chest infections. Patients are required to be stable for the preceding 4 weeks with no changes to medications or ventilator settings.

Other: Acute Intervention

Stable Intervention

EXPERIMENTAL

Patients with established neuromuscular disease admitted to either the Lane Fox Respiratory Unit or Critical Care at St Thomas' Hospital with acute respiratory deteriorations and with the need for respiratory physiotherapy for secretion management.

Other: Stable Intervention

Interventions

Acute Intervention OTHER

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)

Acute Intervention

Stable Intervention OTHER

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)

Stable Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Neuromuscular disease e.g. muscular dystrophy, motor neurons disease
• Respiratory muscle weakness (FVC \<60%, snip \<60%, sleep disordered breathing)
• Clinical evidence of respiratory secretions or cough PEF \<270 and history of LRTI
• Documented clinical stability by supervising clinician
• Neuromuscular disease e.g. muscular dystrophy, motor neurons disease
• Respiratory muscle weakness (FVC \<60%, snip \<60%, sleep disordered breathing)
• Clinical evidence of respiratory secretions or cough PEF \<270
• Admitted with respiratory deterioration

You may not qualify if:

• Decompensated respiratory failure (pH \< 7.35)
• Pregnancy
• Aged \<18, \>80
• Change in ventilator settings in preceding 4 weeks
• Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
• Decompensated respiratory failure (pH \< 7.35), at time of recruitment
• Pregnancy
• Aged \<18, \>80
• Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• B&D Electromedical: collaborator

Study Sites (1)

Guys and St Thomas NHS Foundation

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

• Shah NM, Apps C, Kaltsakas G, Madden-Scott S, Suh ES, D'Cruz RF, Arbane G, Patout M, Lhuillier E, Hart N, Murphy PB. The Effect of Pressure Changes During Mechanical Insufflation-Exsufflation on Respiratory and Airway Physiology. Chest. 2024 Apr;165(4):929-941. doi: 10.1016/j.chest.2023.10.015. Epub 2023 Oct 14.

  PMID: 37844796 DERIVED

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 28, 2016
• Study Start: August 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: February 10, 2020

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)