Trial record 3 of 8 for:    Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2016 by Guy's and St Thomas' NHS Foundation Trust
Sponsor:
Collaborator:
B&D Electromedical
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02753959
First received: April 25, 2016
Last updated: NA
Last verified: February 2016
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in neural respiratory drive (EMGpara) pre to post clearance [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Change in neural respiratory drive (EMGpara) pre to post secretion clearance

  • Change in gas exchange (SpO2 and tcCO2) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in patient comfort defined by VAS pre and post secretion clearance


Estimated Enrollment: 20
Study Start Date: May 2016
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
London, United Kingdom, SE1 7EH
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 
Study First Received: April 25, 2016
Last Updated: April 25, 2016
Health Authority: United Kingdom: Research Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2016