OHSEIT & NIV StepNCT02765360
EIT Study With COPD and OHS Patients (EIT Step 2)
A study testing Treatment Group in people with OHS and COPD, 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). NIV consists of a machine (ventilator) that is blowing air inside a patient's airway through a mask. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- What is being tested?
- Treatment Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to 30 Apr 2017
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- On domiciliary NIV for at least 3 months
- Domiciliary NIV set up following an arterial puncture showing a PaCO2 > 6 kPa
- Compliance of > 4 hours per night
- FEV1 / FVC < 70% and FEV1 < 70% for COPD participants
- FEV1 > 70% for OHS participants
- Previous chest computed tomography for COPD participants
- BMI >35 kg/m2 for OHS participants
Who cannot join
- Pregnancy
- Aged <18, >80
- Significant physical or psychiatric comorbidity that would prevent compliance with trial protocol
- Decompensated respiratory failure (pH < 7.35)
- BMI > 50kg/m2
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 COPD and OHS Patients
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). NIV consists of a machine (ventilator) that is blowing air inside a patient's airway through a mask. NIV provides patients with a bigger breath. Bigger breaths help patients to have a more oxygen and less waste gas (or carbon dioxide) in their body.
These changes can improve outcomes 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 flow of air through the mask
- Pressure support ventilation (PSV) which delivers a constant flow of air through the mask and, on top of that, delivers more flow when the patient begins to inhale
- Volume targeted ventilation which delivers a flow of air through the mask that is adjusted breath by breath in order to achieve a preset volume.
These different type of blowing have consequences on patient comfort as well as on the improvement of their ventilation.
To assess the improvement of the ventilation, currently blood tests are used, 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 on 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 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.
In the supine posture obese patients can generate significant levels of iPEEP that contribute to increased levels of neural respiratory drive compared with the upright posture. There has been much debate regarding the optimal ventilator strategy in patients with obesity related respiratory failure, with uncontrolled trial data to support simple continuous positive airway pressure, pressure support (PSV) NIV and volume targeted (VT) NIV. There has been no robust evidence to suggest superiority of a single mode but post hoc data suggests superior control of sleep disordered breathing in patients in pressure controlled mode. It is unclear whether the extended inspiratory time of pressure controlled mode is allowing superior gas exchange by maintaining airway distension and preventing regional collapse.
In COPD, patients' response to treatment can be influenced by disease heterogeneity with some patients showing even distribution of lung damage and others marked differences throughout the lungs. This variation can lead to significant differences in the lung mechanics in different regions with optimal NIV settings for some regions having potentially deleterious effects on neighbouring zones. It has been shown that control of hypoventilation and improved blood gas exchange is essential in order to improve outcomes with NIV in COPD but is less clear if pressure control ventilation as advocated by Windisch and colleagues is required in order to achieve this effect. Inappropriate settings of NIV can also lead to dynamic distension that results in a decrease of tidal volume and an increase in patient discomfort.
- Being tested
- Treatment Group
- Keywords
- EIT, NIV
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment GroupOther
Participants will be established on the randomised mode of ventilation and will have continuous assessment of the following during the assessment period:
- Electrical impedance tomography
- EMGpara
- SpO2
- tcCO2
- Pneumotachography
- End-tidal CO2 monitoring
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Each patient will be assigned to Continuous Positive Airway Pressure (CPAP), Pressure Support Ventilation (PSV) and Pressure Control Ventilation (PCV) modes in a random order with a 10 minute washout period modes. Receives: Other: Treatment 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
What happens to the lung when ventilation on different modes
Measured: 1 day
Secondary outcomes (5)
Lung volumes on EIT compared with pneumotachography assessed lung volumes
Comparing lung volumes comparison whilst on EIT and pneumotachography
Measured: 1 day
Patient ventilator asynchrony
Measured: 1 day
Neural respiratory drive (EMGpara)
Measured: 1 day
Subjective patient comfort (Visual analogue scale - VAS - Borg scale)
Measured: 1 day
Patient comfort and lung homogeneity
Assessment of patient comfort during ventilation
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 posted6 May 2016 (estimated)
- Study startMay 2016
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OHSStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- Nick Hart, Study chair, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765360
- Sponsor's protocol ID
- 187764 15/LO/1921
- Acronym
- EIT & NIV Step
- Status last verified
- May 2017
- First submitted
- 12 Feb 2016
- Last updated
- 3 May 2017
- 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 3 May 2017. 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 COPD and OHS Patients
- ClinicalTrials.gov ID
- NCT02765360
- Acronym / sponsor ID
- EIT & NIV Step / 187764 15/LO/1921
- Keywords
- EIT, NIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- B&D Electromedical
- Study start
- May 2016
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 6 May 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). NIV consists of a machine (ventilator) that is blowing air inside a patient's airway through a mask. NIV provides patients with a bigger breath. Bigger breaths help patients to have a more oxygen and less waste gas (or carbon dioxide) in their body.
These changes can improve outcomes 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 flow of air through the mask
- Pressure support ventilation (PSV) which delivers a constant flow of air through the mask and, on top of that, delivers more flow when the patient begins to inhale
- Volume targeted ventilation which delivers a flow of air through the mask that is adjusted breath by breath in order to achieve a preset volume.
These different type of blowing have consequences on patient comfort as well as on the improvement of their ventilation.
To assess the improvement of the ventilation, currently blood tests are used, 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 on 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 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.
In the supine posture obese patients can generate significant levels of iPEEP that contribute to increased levels of neural respiratory drive compared with the upright posture. There has been much debate regarding the optimal ventilator strategy in patients with obesity related respiratory failure, with uncontrolled trial data to support simple continuous positive airway pressure, pressure support (PSV) NIV and volume targeted (VT) NIV. There has been no robust evidence to suggest superiority of a single mode but post hoc data suggests superior control of sleep disordered breathing in patients in pressure controlled mode. It is unclear whether the extended inspiratory time of pressure controlled mode is allowing superior gas exchange by maintaining airway distension and preventing regional collapse.
In COPD, patients' response to treatment can be influenced by disease heterogeneity with some patients showing even distribution of lung damage and others marked differences throughout the lungs. This variation can lead to significant differences in the lung mechanics in different regions with optimal NIV settings for some regions having potentially deleterious effects on neighbouring zones. It has been shown that control of hypoventilation and improved blood gas exchange is essential in order to improve outcomes with NIV in COPD but is less clear if pressure control ventilation as advocated by Windisch and colleagues is required in order to achieve this effect. Inappropriate settings of NIV can also lead to dynamic distension that results in a decrease of tidal volume and an increase in patient discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Treatment GroupEach patient will be assigned to Continuous Positive Airway Pressure (CPAP), Pressure Support Ventilation (PSV) and Pressure Control Ventilation (PCV) modes in a random order with a 10 minute washout period modes. |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- On domiciliary NIV for at least 3 months
- Domiciliary NIV set up following an arterial puncture showing a PaCO2 > 6 kPa
- Compliance of > 4 hours per night
- FEV1 / FVC < 70% and FEV1 < 70% for COPD participants
- FEV1 > 70% for OHS participants
Key exclusion criteria (5 listed)
- Pregnancy
- Aged <18, >80
- Significant physical or psychiatric comorbidity that would prevent compliance with trial protocol
- Decompensated respiratory failure (pH < 7.35)
- BMI > 50kg/m2
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 |
|---|---|---|
| Treatment GroupParticipants will be established on the randomised mode of ventilation and will have continuous assessment of the following during the assessment period: * Electrical impedance tomography * EMGpara * SpO2 * tcCO2 * Pneumotachography * End-tidal CO2 monitoring | Other | Treatment |
Primary outcome
Characteristics seen during ventilation in different modes of ventilation
Time frame: 1 day
What happens to the lung when ventilation on different modes
5 secondary outcomes
Lung volumes on EIT compared with pneumotachography assessed lung volumes
Time frame: 1 day
Patient ventilator asynchrony
Time frame: 1 day
Neural respiratory drive (EMGpara)
Time frame: 1 day
Subjective patient comfort (Visual analogue scale - VAS - Borg scale)
Time frame: 1 day
Patient comfort and lung homogeneity
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 3 May 2017.
- 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.
Nick Hart study chair
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Group in people with OHS and COPD, 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 7 inclusion and 5 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 3 May 2017. 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?
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 3 May 2017.