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COPDEIT-GuideNCT07810283

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

An observational study of COPD and Non Invasive Ventilation (NIV), run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COPD, Non Invasive Ventilation (NIV), Obesity
What is being tested?
electrical impedance tomography
Type of treatment
Medical device
How many people
20 participants
Where
1 siteUnited Kingdom
Study dates
27 Aug 2026to 1 Sep 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • Psychosocial factors attributable to non-concordance
  • Excessive mask leak contributing to non-concordance
  • Mental health diagnosis contributing to non-concordance
  • Pregnancy
  • 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 FEV1: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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site
  • Royal Free Hospital

    London

Other trials in United Kingdom

About this study

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.

Read more

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.

Being tested
electrical impedance tomography
Keywords
observational, EIT
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electrical impedance tomographyDevice

    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.

Study groups in NCT07810283
Study groupRoleWhat they receive
NIVUse 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.
Receives: Device: electrical impedance tomography
MI:EUse 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.
Receives: Device: electrical impedance tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concordance with NIV

    Concordance with NIV

    Measured: 1month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2026
  2. Study start27 Aug 2026
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07810283
Sponsor's protocol ID
207264
Acronym
EIT-Guide
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of COPD and Non Invasive Ventilation (NIV), run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concordance with NIV (time frame: 1month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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