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Trial record 3 of 3 for:    Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance

Changes in Regional Lung Ventilation Following Mechanical Insufflation-Exsufflation (MIE and EIT)

This study is currently recruiting participants.
Verified February 2017 by Guy's and St Thomas' NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT02753959
First Posted: April 28, 2016
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
B&D Electromedical
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust
  Purpose

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.


Condition Intervention
Neuromuscular Diseases Other: Acute Intervention Other: Stable Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Changes in Regional Lung Ventilation Following Mechanical Insufflation-Exsufflation

Resource links provided by NLM:


Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • Reduction in the regional ventilation delays and Increase in homogeneity of ventilation post MIE vs baseline. [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • Change in neural respiratory drive (EMGpara) pre to post clearance [ Time Frame: 1 day ]
    Change in neural respiratory drive (EMGpara) pre to post secretion clearance

  • Change in gas exchange (SpO2 and tcCO2) [ Time Frame: 1 day ]
    Change in gas exchange, measured by taking SpO2 measurements and tCO2 measurements before and after secretion clearance

  • Subjective patient comfort (Visual analogue scale - VAS) [ Time Frame: 1 day ]
    Change in patient comfort defined by VAS pre and post secretion clearance


Estimated Enrollment: 20
Study Start Date: August 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acute Intervention
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

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)
Experimental: Stable Intervention
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

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)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: STABLE

  • 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

Inclusion Criteria: ACUTE

  • 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

Exclusion Criteria: STABLE

  • 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

Exclusion Criteria: ACUTE

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753959


Contacts
Contact: Patrick Murphy 0207 188 3446 patrick.murphy@gstt.nhs.uk
Contact: Gill Arbane 0207 188 8070 gill.arbane@gstt.nhs.uk

Locations
United Kingdom
Guys and St Thomas NHS Foundation Recruiting
London, United Kingdom, SE1 7EH
Contact: Gill Arbane    02071887070    gill.arbane@gstt.nhs.uk   
Contact: Nick Hart         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
B&D Electromedical
  More Information

Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02753959     History of Changes
Other Study ID Numbers: PM Mar 16
First Submitted: April 25, 2016
First Posted: April 28, 2016
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases