Healthy ParticipantsPhase 1EIT Step 1NCT02828007
EIT Study With Healthy Patients
A Phase 1 study testing NIV Group in people with Healthy Participants, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Patients with severe respiratory diseases such as chronic obstructive pulmonary disease (COPD) or obesity-hypoventilation syndrome (OHS) can benefit from having non-invasive ventilation (NIV). Non-invasive ventilation consists of a machine (ventilator) that is blowing air through a mask. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- NIV Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of any underlying lung disease
- FEV1/FVC > 70%
Who cannot join
- Pregnancy
- Aged <18, >80
- Significant physical or psychiatric comorbidity
- that would prevent compliance with trial protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Lung Ventilation With Different Modes of Non-invasive Ventilation in Healthy Subjects
Patients with severe respiratory diseases such as chronic obstructive pulmonary disease (COPD) or obesity-hypoventilation syndrome (OHS) can benefit from having non-invasive ventilation (NIV). Non-invasive ventilation consists of a machine (ventilator) that is blowing air through a mask. NIV provides patients with a bigger expansion of their lung when they are breathing. This better expansion helps patients to have more oxygen and less waste gas (or carbon dioxide) in their body.
These improvements enhance survival and quality of life. In order to provide appropriate ventilation for each patient, the ventilator can generate different types of blowing:
Read more
- Continuous positive airway pressure (CPAP) which delivers a constant pressure to the mask
- Pressure support ventilation (PSV) which delivers a constant pressure to the mask and, on top of that, delivers more pressure when the patient begins to breathe in.
- Pressure control ventilation (PCV), which is similar to PSV, but use a fixed time to generate the flow when the patient begins to breathe in.
These different types of blowing have consequences on patient comfort as well as on the improvement of their ventilation.
To assess the improvement of the ventilation, the investigators currently use blood tests, however, these reflect overall output and may miss more subtle changes in breathing that could affect how patients feel.
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 by the ventilator. It allows a non-invasive assessment of the effect of NIV onto lung ventilation in real-time.
The investigators hope to use the EIT technology to assess in real-time patients lung ventilation when they are using the NIV. The investigators hope that EIT will provide them with information on which type of blowing is more effective and more comfortable than the others.
Read the detailed description
Chronic lung disease can sometimes progress to the extent that patients can no longer clear the waste gas from their blood. Treatment can be offered with a mask and machine (ventilator) that helps people breathe and aims to improve their lung condition. It is common for people's lungs to be affected variably, i.e. left more than right or top of lung more than bases of lungs. The way in which the ventilator is set may affect how well the machine deals with these differences. If the lung is better ventilator patients may find the machine more comfortable and it may be more effective.
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 by the ventilator. It allows the assessment of these differences, which previously required the use of invasive equipment to obtain.
Optimising ventilator settings in the administration of non-invasive ventilation (NIV) can be improved with the addition of individual physiological data. This approach is limited due to the invasive techniques required to obtain this information, often leading to less ideal NIV settings promoting patient-ventilator asynchrony. It has been recently demonstrated by our group that all patients established on domiciliary NIV have a degree of patient-ventilator asynchrony and that the commonest type of asynchrony are triggering issues. Triggering asynchrony is promoted by mismatch between a patient's intrinsic positive end-expiratory pressure (iPEEP) and applied expiratory positive airway pressure (EPAP) with these ineffective efforts contributing to an increased work of breathing and patient discomfort. Previous strategies used to optimise patient triggering have involved the placement of oesophageal catheters in order to measure neural respiratory drive (NRD) to the diaphragm by electromyography (EMG) but again this process is invasive and often poorly tolerated. Electrical Impedance Tomography (EIT) is a non-invasive, bedside monitoring technique that provides semi-continuous, real-time information about the regional distribution of the changes in electrical resistivity of the lung tissue due to variations in ventilation in relation to a reference state.
Information is gained by repeatedly injecting small alternating electric currents (usually 5 mA) at high frequency of 50 - 80 kHz through a system of skin electrodes (usually 16) applied circumferentially around the thorax in a single plane between the 4th and 6th intercostal space. While an adjacent pair of electrodes 'injects' the current ('adjacent drive configuration'), all the remaining adjacent passive electrode pairs measure the differences in electric potential. A resistivity (impedance) image is reconstructed from this data by a mathematical algorithm using a two dimensional model and a simplified shape to represent the thoracic cross-section.
The resulting image possesses a high temporal and functional resolution making it possible to monitor dynamic physiological phenomena (e.g. delay in regional inflation or recruitment) on a breath by breath basis. It is important to realize that the EIT images are based on image reconstruction techniques that require at least one measurement on a well-defined reference state. All quantitative data are related to this reference and can only indirectly quantify (relative) changes in local lung impedance (but not absolute).
EIT can be used in mechanically ventilated patients to assess recruitment and to optimise ventilator settings to reduce risk of iatrogenic ventilator associated lung injury.
To date, EIT has only been validated in patient invasively ventilated or during self-ventilation.
The investigators hope to use the EIT technology to assess patients breathing using different ventilator modes in order to see if one is more effective and or more comfortable than the others. The investigators can use this information to help them set ventilators for future patients.
- Conditions
- Healthy Participants
- Being tested
- NIV Group
- Keywords
- EIT, NIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIV GroupDevice
Each patient will be using Non Invasive Ventilation (NIV) and will use it on each possible ventilation mode in a random order with a 10 minutes washout period between modes.
| Study group | Role | What they receive |
|---|---|---|
| Treatment/Intervention | Experimental | Each patient will be using Non Invasive Ventilation (NIV) and will use it on each possible ventilation mode in a random order with a 10 minutes washout period between modes. Receives: Device: NIV Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics seen during ventilation in different modes of ventilation
Measured: 1 day
Secondary outcomes (5)
Correlation between tidal volume assessed by EIT
Measured: 1 day
Correlation between tidal volume assessed by NIV software
Measured: 1 day
Detection of patient ventilator asynchrony using physiological measurements
Measured: 1 day
Measurements of Neural Respiratory Drive using parasternal EMG
Measured: 1 day
Patient Comfort using Visual Analogue Scale
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- B&D Electromedical
- Responsible party
- Sponsor
- Investigators
- Nicholas Hart, Study chair, GSTT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828007
- Sponsor's protocol ID
- 185543
- Acronym
- EIT Step 1
- Status last verified
- Jul 2016
- First submitted
- 12 Feb 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Lung Ventilation With Different Modes of Non-invasive Ventilation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02828007
- Acronym / sponsor ID
- EIT Step 1 / 185543
- Conditions
- Healthy Participants
- Keywords
- EIT, NIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- B&D Electromedical
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
Patients with severe respiratory diseases such as chronic obstructive pulmonary disease (COPD) or obesity-hypoventilation syndrome (OHS) can benefit from having non-invasive ventilation (NIV). Non-invasive ventilation consists of a machine (ventilator) that is blowing air through a mask. NIV provides patients with a bigger expansion of their lung when they are breathing. This better expansion helps patients to have more oxygen and less waste gas (or carbon dioxide) in their body.
These improvements enhance survival and quality of life. In order to provide appropriate ventilation for each patient, the ventilator can generate different types of blowing:
- Continuous positive airway pressure (CPAP) which delivers a constant pressure to the mask
- Pressure support ventilation (PSV) which delivers a constant pressure to the mask and, on top of that, delivers more pressure when the patient begins to breathe in.
- Pressure control ventilation (PCV), which is similar to PSV, but use a fixed time to generate the flow when the patient begins to breathe in.
These different types of blowing have consequences on patient comfort as well as on the improvement of their ventilation.
To assess the improvement of the ventilation, the investigators currently use blood tests, however, these reflect overall output and may miss more subtle changes in breathing that could affect how patients feel.
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 by the ventilator. It allows a non-invasive assessment of the effect of NIV onto lung ventilation in real-time.
The investigators hope to use the EIT technology to assess in real-time patients lung ventilation when they are using the NIV. The investigators hope that EIT will provide them with information on which type of blowing is more effective and more comfortable than the others.
Detailed description
Chronic lung disease can sometimes progress to the extent that patients can no longer clear the waste gas from their blood. Treatment can be offered with a mask and machine (ventilator) that helps people breathe and aims to improve their lung condition. It is common for people's lungs to be affected variably, i.e. left more than right or top of lung more than bases of lungs. The way in which the ventilator is set may affect how well the machine deals with these differences. If the lung is better ventilator patients may find the machine more comfortable and it may be more effective.
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 by the ventilator. It allows the assessment of these differences, which previously required the use of invasive equipment to obtain.
Optimising ventilator settings in the administration of non-invasive ventilation (NIV) can be improved with the addition of individual physiological data. This approach is limited due to the invasive techniques required to obtain this information, often leading to less ideal NIV settings promoting patient-ventilator asynchrony. It has been recently demonstrated by our group that all patients established on domiciliary NIV have a degree of patient-ventilator asynchrony and that the commonest type of asynchrony are triggering issues. Triggering asynchrony is promoted by mismatch between a patient's intrinsic positive end-expiratory pressure (iPEEP) and applied expiratory positive airway pressure (EPAP) with these ineffective efforts contributing to an increased work of breathing and patient discomfort. Previous strategies used to optimise patient triggering have involved the placement of oesophageal catheters in order to measure neural respiratory drive (NRD) to the diaphragm by electromyography (EMG) but again this process is invasive and often poorly tolerated. Electrical Impedance Tomography (EIT) is a non-invasive, bedside monitoring technique that provides semi-continuous, real-time information about the regional distribution of the changes in electrical resistivity of the lung tissue due to variations in ventilation in relation to a reference state.
Information is gained by repeatedly injecting small alternating electric currents (usually 5 mA) at high frequency of 50 - 80 kHz through a system of skin electrodes (usually 16) applied circumferentially around the thorax in a single plane between the 4th and 6th intercostal space. While an adjacent pair of electrodes 'injects' the current ('adjacent drive configuration'), all the remaining adjacent passive electrode pairs measure the differences in electric potential. A resistivity (impedance) image is reconstructed from this data by a mathematical algorithm using a two dimensional model and a simplified shape to represent the thoracic cross-section.
The resulting image possesses a high temporal and functional resolution making it possible to monitor dynamic physiological phenomena (e.g. delay in regional inflation or recruitment) on a breath by breath basis. It is important to realize that the EIT images are based on image reconstruction techniques that require at least one measurement on a well-defined reference state. All quantitative data are related to this reference and can only indirectly quantify (relative) changes in local lung impedance (but not absolute).
EIT can be used in mechanically ventilated patients to assess recruitment and to optimise ventilator settings to reduce risk of iatrogenic ventilator associated lung injury.
To date, EIT has only been validated in patient invasively ventilated or during self-ventilation.
The investigators hope to use the EIT technology to assess patients breathing using different ventilator modes in order to see if one is more effective and or more comfortable than the others. The investigators can use this information to help them set ventilators for future patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment/Intervention | Experimental | Device: NIV GroupEach patient will be using Non Invasive Ventilation (NIV) and will use it on each possible ventilation mode in a random order with a 10 minutes washout period between modes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Absence of any underlying lung disease
- FEV1/FVC > 70%
Key exclusion criteria (4 listed)
- Pregnancy
- Aged <18, >80
- Significant physical or psychiatric comorbidity
- that would prevent compliance with trial protocol
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 |
|---|---|---|
| NIV GroupEach patient will be using Non Invasive Ventilation (NIV) and will use it on each possible ventilation mode in a random order with a 10 minutes washout period between modes. | Device | Treatment/Intervention |
Primary outcome
Characteristics seen during ventilation in different modes of ventilation
Time frame: 1 day
5 secondary outcomes
Correlation between tidal volume assessed by EIT
Time frame: 1 day
Correlation between tidal volume assessed by NIV software
Time frame: 1 day
Detection of patient ventilator asynchrony using physiological measurements
Time frame: 1 day
Measurements of Neural Respiratory Drive using parasternal EMG
Time frame: 1 day
Patient Comfort using Visual Analogue Scale
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- 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. This study is not recruiting at the moment.
Nicholas Hart study chair
GSTT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NIV Group in people with Healthy Participants, run by Guy's and St Thomas' 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 28 Nov 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characteristics seen during ventilation in different modes of ventilation (time frame: 1 day). 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 28 Nov 2016.