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
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
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.
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 →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.
Work package 1:
Work package 2:
Inclusion Criteria:
Work package 1:
Work package 2:
Exclusion Criteria:
Exclusion criteria work package 1:
to EIT:
Exclusion criteria work package 2:
Contraindication to EIT:
Evidence of obstructive airways disease :FVC\<0.7.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Concordance with NIV
Concordance with NIV
Time frame: 1month
Plan to share: No
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Pulmonary Disease, Chronic Obstructive →
Royal Free Hospital NHS Foundation Trust