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.
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.
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.
- Conditions
- COPD, Non Invasive Ventilation (NIV), Obesity, Neuromuscular Disability, Electrical Impedance Tomography
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted9 Sep 2026
- Study start27 Aug 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Electrical Impedance Tomography to Guide Non-invasive Respiratory Interventions in Chronic Respiratory Disease
- ClinicalTrials.gov ID
- NCT07810283
- Acronym / sponsor ID
- EIT-Guide / 207264
- Conditions
- COPD, Non Invasive Ventilation (NIV), Obesity, Neuromuscular Disability, Electrical Impedance Tomography
- Keywords
- observational, EIT
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV | – | Device: electrical impedance tomographyUse 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. |
| MI:E | – | Device: electrical impedance tomographyUse 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (8 listed)
- Work package 1:
- 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
Key exclusion criteria (29 listed)
- Unable to provide informed consent
- Contraindication to EIT:
- Chest circumference < 80cm or > 116cm
- Pregnancy
- Evidence of obstructive airways disease FEV1:FVC<0.7.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical impedance tomographyElectrical 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. | Device | MI:E, NIV |
Primary outcome
Concordance with NIV
Time frame: 1month
Concordance with NIV
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.