ClinicalTrials.gg
Enrolling by invitationNCT07810283EIT-GuideUpdated Sep 9, 2026

The Feasibility of Electrical Impedance Tomography to Guide Non-invasive Respiratory Interventions in Chronic Respiratory Disease

An observational study in COPD, Non Invasive Ventilation (NIV) and Obesity, sponsored by Royal Free Hospital NHS Foundation Trust. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Royal Free Hospital NHS Foundation Trust · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to use Electrical Impedance Tomography (EIT) to optimise breathing machines for people with problems with their breathing. This might improve their ability to use their breathing machine. By providing real-time pictures of the lungs, EIT can help clinicians tailor breathing machine settings to meet each persons needs.

Long term respiratory failure is a serious condition that causes extreme difficulty breathing. There are a lot of people in the UK with respiratory failure. It costs the NHS a lot of money to support these people. People with long term respiratory failure often spend a lot of time in hospital.

Non-invasive ventilation (NIV) is a key treatment for these patients. NIV is a breathing machine that supports breathing and helps get rid of waste gases (including carbon dioxide) from the lungs. Cough assist helps people to cough and clear secretion. Lots of patients find using breathing machine hard. It can be difficult to set the machines up to suit each persons needs.

Electrical Impedance Tomography (EIT) is a promising technology that provides real-time pictures of the lungs without radiation exposure. A chest belt sends painless, harmless low-level electrical currents through the lungs. This creates an instant picture of the lungs. EIT has shown to be useful in critical care settings to optimise breathing machine settings. EIT in respiratory failure has not been tested.

Project Goal: Assess if Electrical Impedance Tomography (EIT) can make breathing machine settings better for people with respiratory failure.

Objectives:

Work package 1

  • Use EIT to look at and adjust settings on breathing machines (NIV).
  • Check if adjustments using EIT help patients use their breathing machines more often.
  • Ask people if they feel any better with the machine on the new settings
  • Ask people about changes in their symptoms after the changes on the machines have been made Work package 2
  • Use EIT to observe lung air movement during mechanical insufflation-exsufflation (MI:E).

Project Structure

Recruitment:

We aim to have 20 participants from the Royal Free Hospital. We aim to have 5-10 participants in each part of the study.

Baseline Measurements:

Work package 1 Body metrics, current NIV therapy, transcutaneous CO2 (TcCO2), spirometry, and forced oscillation technique (FOT), capillary blood gas(CBG).

Work package 2 Spirometry, sniff nasal inspiratory pressure (SNIP), and peak cough flow, capillary blood gas.

Interventions:

Work package 1 Use EIT to improve settings on the breathing machine. Patients will wear the EIT belt to get a baseline. Expert clinicians will change breathing machine settings whilst looking at the EIT pictures. New and improved settings will be tested for 2-4 hours. Patients will then be sent home on these new settings and tests will be redone after one month on the new and improved settings.

Work package 2 Use EIT to monitor the effects of MI:E. Participants will undergo five short MI:E sessions of 1-2minutes with a 20minute rest between sessions, with EIT attached, adjusting pressures by 20%. EIT will track the changes in how air moves within the lungs during different MI:E prescriptions.

Data Analysis:

We will compare the tests as baseline and one month follow-up using statistics. The statistical tests will help us work out if using EIT to guide the NIV and M I:E machine settings makes them better for patients.

02

Conditions studied

  • COPD
  • Non Invasive Ventilation (NIV)
  • Obesity
  • Neuromuscular Disability
  • Electrical Impedance Tomography

Keywords

  • observational
  • EIT
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's planned enrollment of 20 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Royal Free Hospital NHS Foundation Trust is the lead sponsor of 34 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Work package 1:

  • Patients diagnosed with chronic respiratory failure
  • Requiring domiciliary NIV and non-concordant with NIV (\<4hrs/night for 70% in the last 1month)
  • Age ≥18years

Work package 2:

  • Age ≥18years
  • Patients diagnosed with a neuromuscular disease
  • Currently use or have previously used MI:E for clinical use or as part of a research study

Eligibility criteria

Inclusion Criteria:

  • Work package 1:

    • Patients diagnosed with chronic respiratory failure
    • Requiring domiciliary NIV and non-concordant with NIV (\<4hrs/night for 70% in the last 1month)
    • Age ≥18years

Work package 2:

  • Age ≥18years
  • Patients diagnosed with a neuromuscular disease
  • Currently use or have previously used MI:E for clinical use or as part of a research study

Exclusion Criteria:

  • Exclusion criteria work package 1:

    • Unable to provide
    • to EIT:

      • Active implantable cardiac device
      • Active pacemaker
      • Open wound over the site of the EIT belt
    • Chest circumference \< 80cm or > 116cm
    • Psychosocial factors attributable to non-concordance
    • Excessive mask leak contributing to non-concordance
    • Mental health diagnosis contributing to non-concordance
    • Pregnancy

Exclusion criteria work package 2:

  • Unable to provide informed consent
  • Contraindication to EIT:

    • Active implantable cardiac device
    • Active pacemaker
    • Open wound over the site of the EIT belt
  • Chest circumference \< 80cm or > 116cm
  • Pregnancy
  • Evidence of obstructive airways disease :FVC\<0.7.

    • Contraindication to MI:E:
    • Un-drained pneumothorax.
    • Severe bronchospasm.
    • Head injury with Intercranial pressure (ICP) >25 mm Hg.
    • Severe arterial hypotension (mean arterial pressure \<65 mm Hg).
    • Tracheoesophageal fistula.
    • Significant haemoptysis.
    • Facial fractures.
    • Vomiting.
    • Flail segment
    • Epistaxis within 2 weeks.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • NIV

    Use EIT to improve settings on the breathing machine. Patients will wear the EIT belt to get a baseline. Expert clinicians will change breathing machine settings whilst looking at the EIT pictures. New and improved settings will be tested for 2-4 hours. Patients will then be sent home on these new settings and tests will be redone after one month on the new and improved settings.

    Device: electrical impedance tomography

  • MI:E

    Use EIT to monitor the effects of MI:E. Participants will undergo five short MI:E sessions of 1-2minutes with a 20minute rest between sessions, with EIT attached, adjusting pressures by 20%. EIT will track the changes in how air moves within the lungs during different MI:E prescriptions.

    Device: electrical impedance tomography

Interventions

  • Deviceelectrical impedance tomography

    Electrical Impedance Tomography (EIT) is a promising technology that provides real-time pictures of the lungs without radiation exposure. A chest belt sends painless, harmless low-level electrical currents through the lungs. This creates an instant picture of the lungs.

06

What researchers measure

Primary outcomes

  1. Concordance with NIV

    Concordance with NIV

    Time frame: 1month

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07810283
Lead sponsor
Royal Free Hospital NHS Foundation Trust
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Aug 27, 2026
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Sep 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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