COPDNCT03503123
Deventilation Dyspnea in COPD Patients Using NIV
An observational study of COPD and Dyspnea, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Non-invasive ventilation (NIV) has shown to be an effective therapy for patients with Chronic Obstructive Pulmonary Disease (COPD) with Chronic Hypercapnic Respiratory Failure (CHRF). However, these COPD patients often report severe dyspnoea after switching off from NIV therapy, which leads to discomfort and distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Dyspnea, Mechanical Ventilation Complication
- What is being tested?
- Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements.
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Aug 2019to 5 Mar 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the University Medical Center Groningen (UMCG). There is a large population of COPD patients using NIV known at the Home Mechanical Ventilation (HMV) Centre (around 120 patients). The pulmonologists know already at least 10 patients who suffer extremely from deventilation dyspnoea, which could possibly participate in the study.
Who may be able to join
- COPD with a NIV indication using chronic NIV
- Age > 18 years
- With or without deventilation dyspnea when switching off from NIV (depending on group/cohort)
- Written informed consent is obtained
Who cannot join
- COPD exacerbation within 2 weeks preceding the study
- Modification of ventilation within 2 weeks preceding the study
- Having a poor compliance with NIV (usage of <4 h/day)
- Having other disorders leading to respiratory failure (such as morbid obesity, kyphoscoliosis, neuromuscular diseases, tuberculosis)
- Not being able to sleep 1.5 hour in the afternoon
- Having spinal injury, BMI>50, damaged or inflamed skin around the thorax or a cardiac pacemaker or other implanted devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deventilation Dyspnea in Patients With Chronic Obstructive Pulmonary Disease After Switching Off From Non-invasive Ventilation
Non-invasive ventilation (NIV) has shown to be an effective therapy for patients with Chronic Obstructive Pulmonary Disease (COPD) with Chronic Hypercapnic Respiratory Failure (CHRF). However, these COPD patients often report severe dyspnoea after switching off from NIV therapy, which leads to discomfort and distress. Currently, it is not known what causes this deventilation dyspnoea and therefore a possible treatment to prevent deventilation dyspnoea is not available. This study investigates possible mechanisms underlying the phenomenon of deventilation dyspnoea in COPD patients by monitoring the effects of NIV on the patient during an afternoon sleep.
Read the detailed description
Rationale: Non-invasive ventilation (NIV) has shown to be an effective therapy for patients with Chronic Obstructive Pulmonary Disease (COPD) with Chronic Hypercapnic Respiratory Failure (CHRF). However, these COPD patients often report severe dyspnoea after switching off from NIV therapy, which leads to discomfort and distress. Currently, it is not known what causes this deventilation dyspnoea and therefore a possible treatment to prevent deventilation dyspnoea is not available.
Objective: 1) To investigate what mechanisms underlie the phenomenon of deventilation dyspnoea in COPD patients. 2) To investigate how the change in electrical impedance, measured with electrical impedance tomography (EIT), is related to the change in inspiratory capacity (IC) before and after sleep.
Study design: This study is an observational cohort study analysing changes occurring due to NIV which could explain the existence of deventilation dyspnoea in certain COPD patients using NIV. Ten patients with and ten patients without deventilation dyspnoea will visit the hospital for an afternoon sleep, during and after which several non-invasive measurements are performed to analyse the changes occurring during and after switching off NIV. In order to investigate the deventilation problem, we will measure:
- the degree of hyperinflation due to NIV: this will be assessed by measuring the change in end-expiratory lung volume (EELV) with EIT before, during and after NIV, and the change in IC before and after sleeping with NIV.
- the reduction of respiratory muscle activity due to NIV: this will be assessed by the change in electromyography of the frontal diaphragm before, during and after NIV.
- the effectiveness of NIV in reducing CO2 level: this will be assessed with transcutaneous CO2 measurements (PtcCO2) before, during and after NIV.
- the degree of deventilation dyspnoea before and after the afternoon sleep: this will be assessed with a 10-point Borg Scale.
Study population: Twenty severe COPD patients (age>18yr) using chronic NIV will be included in the study: 10 patients with severe symptoms of deventilation dyspnoea (Borg Dyspnoea Scale ≥ 5) and 10 patients without symptoms of deventilation dyspnoea, matched with regard to the degree of static lung hyperinflation and NIV settings.
Main study parameters/endpoints: Knowledge about the changes occurring during NIV in patients with COPD with deventilation dyspnoea. The percent change in EELV, IC, respiratory muscle activity and PtcCO2 will be calculated for both groups and correlated with the degree of deventilation dyspnoea.
- Conditions
- COPD, Dyspnea, Mechanical Ventilation Complication
- Being tested
- Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements.Device
Both groups get the same exposures: with measure physiology in both groups by using non-invasive measurement techniques. The techniques we use are Electrical Impedance Tomography to determine degree of hyperinflation. We use Electromyography to analyse respiratory drive. We measure transcutaneous carbon dioxide to assess the effects of non-invasive ventilation. Thereby, we will perform lung function tests.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with deventilation dyspnoea | Ten severe COPD patients (age>18yr) using chronic NIV with severe symptoms of deventilation dyspnoea (Borg Dyspnoea Scale ≥ 5) Receives: Device: Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements. | |
| COPD patients without deventilation dyspnoea | Ten severe COPD patients (age>18yr) using chronic NIV without symptoms of deventilation dyspnoea, matched with the first cohort/group with regard to the degree of static lung hyperinflation and NIV settings. Receives: Device: Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-expiratory lung volume
The change in end-expiratory lung volume due to NIV-usage
Measured: Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.
Inspiratory capacity
The change in inspiratory capacity due to NIV-usage
Measured: Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.
Respiratory muscle activity
The change in respiratory muscle activity due to NIV-usage
Measured: Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.
Transcutaneous carbon dioxide
The change in transcutaneous carbon dioxide due to NIV-usage
Measured: Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.
Secondary outcomes (1)
Correlation of inspiratory capacity with end-expiratory lung volume
To validate Electrical Impedance Tomography measurements to determine end-expiratory lung volume, we will compare these outcomes with the golden standard inspiratory capacity.
Measured: Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start15 Aug 2019
- Primary completion15 Dec 2023
- Study completion5 Mar 2024
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marieke Duiverman, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503123
- Sponsor's protocol ID
- 201800263
- Status last verified
- May 2024
- First submitted
- 9 Apr 2018
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deventilation Dyspnea in Patients With Chronic Obstructive Pulmonary Disease After Switching Off From Non-invasive Ventilation
- ClinicalTrials.gov ID
- NCT03503123
- Acronym / sponsor ID
- 201800263
- Conditions
- COPD, Dyspnea, Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 19 Apr 2018 (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.
Non-invasive ventilation (NIV) has shown to be an effective therapy for patients with Chronic Obstructive Pulmonary Disease (COPD) with Chronic Hypercapnic Respiratory Failure (CHRF). However, these COPD patients often report severe dyspnoea after switching off from NIV therapy, which leads to discomfort and distress. Currently, it is not known what causes this deventilation dyspnoea and therefore a possible treatment to prevent deventilation dyspnoea is not available. This study investigates possible mechanisms underlying the phenomenon of deventilation dyspnoea in COPD patients by monitoring the effects of NIV on the patient during an afternoon sleep.
Detailed description
Rationale: Non-invasive ventilation (NIV) has shown to be an effective therapy for patients with Chronic Obstructive Pulmonary Disease (COPD) with Chronic Hypercapnic Respiratory Failure (CHRF). However, these COPD patients often report severe dyspnoea after switching off from NIV therapy, which leads to discomfort and distress. Currently, it is not known what causes this deventilation dyspnoea and therefore a possible treatment to prevent deventilation dyspnoea is not available.
Objective: 1) To investigate what mechanisms underlie the phenomenon of deventilation dyspnoea in COPD patients. 2) To investigate how the change in electrical impedance, measured with electrical impedance tomography (EIT), is related to the change in inspiratory capacity (IC) before and after sleep.
Study design: This study is an observational cohort study analysing changes occurring due to NIV which could explain the existence of deventilation dyspnoea in certain COPD patients using NIV. Ten patients with and ten patients without deventilation dyspnoea will visit the hospital for an afternoon sleep, during and after which several non-invasive measurements are performed to analyse the changes occurring during and after switching off NIV. In order to investigate the deventilation problem, we will measure:
- the degree of hyperinflation due to NIV: this will be assessed by measuring the change in end-expiratory lung volume (EELV) with EIT before, during and after NIV, and the change in IC before and after sleeping with NIV.
- the reduction of respiratory muscle activity due to NIV: this will be assessed by the change in electromyography of the frontal diaphragm before, during and after NIV.
- the effectiveness of NIV in reducing CO2 level: this will be assessed with transcutaneous CO2 measurements (PtcCO2) before, during and after NIV.
- the degree of deventilation dyspnoea before and after the afternoon sleep: this will be assessed with a 10-point Borg Scale.
Study population: Twenty severe COPD patients (age>18yr) using chronic NIV will be included in the study: 10 patients with severe symptoms of deventilation dyspnoea (Borg Dyspnoea Scale ≥ 5) and 10 patients without symptoms of deventilation dyspnoea, matched with regard to the degree of static lung hyperinflation and NIV settings.
Main study parameters/endpoints: Knowledge about the changes occurring during NIV in patients with COPD with deventilation dyspnoea. The percent change in EELV, IC, respiratory muscle activity and PtcCO2 will be calculated for both groups and correlated with the degree of deventilation dyspnoea.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients with deventilation dyspnoea | – | Device: Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements.Ten severe COPD patients (age>18yr) using chronic NIV with severe symptoms of deventilation dyspnoea (Borg Dyspnoea Scale ≥ 5) |
| COPD patients without deventilation dyspnoea | – | Device: Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements.Ten severe COPD patients (age>18yr) using chronic NIV without symptoms of deventilation dyspnoea, matched with the first cohort/group with regard to the degree of static lung hyperinflation and NIV settings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the University Medical Center Groningen (UMCG). There is a large population of COPD patients using NIV known at the Home Mechanical Ventilation (HMV) Centre (around 120 patients). The pulmonologists know already at least 10 patients who suffer extremely from deventilation dyspnoea, which could possibly participate in the study.
Key inclusion criteria (4 listed)
- COPD with a NIV indication using chronic NIV
- Age > 18 years
- With or without deventilation dyspnea when switching off from NIV (depending on group/cohort)
- Written informed consent is obtained
Key exclusion criteria (6 listed)
- COPD exacerbation within 2 weeks preceding the study
- Modification of ventilation within 2 weeks preceding the study
- Having a poor compliance with NIV (usage of <4 h/day)
- Having other disorders leading to respiratory failure (such as morbid obesity, kyphoscoliosis, neuromuscular diseases, tuberculosis)
- Not being able to sleep 1.5 hour in the afternoon
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 |
|---|---|---|
| Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements.Both groups get the same exposures: with measure physiology in both groups by using non-invasive measurement techniques. The techniques we use are Electrical Impedance Tomography to determine degree of hyperinflation. We use Electromyography to analyse respiratory drive. We measure transcutaneous carbon dioxide to assess the effects of non-invasive ventilation. Thereby, we will perform lung function tests. | Device | COPD patients with deventilation dyspnoea, COPD patients without deventilation dyspnoea |
Primary outcome
End-expiratory lung volume
Time frame: Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.
The change in end-expiratory lung volume due to NIV-usage
Inspiratory capacity
Time frame: Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.
The change in inspiratory capacity due to NIV-usage
Respiratory muscle activity
Time frame: Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.
The change in respiratory muscle activity due to NIV-usage
Transcutaneous carbon dioxide
Time frame: Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.
The change in transcutaneous carbon dioxide due to NIV-usage
1 secondary outcome
Correlation of inspiratory capacity with end-expiratory lung volume
Time frame: Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.
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 10 May 2024.
- 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.
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 Dyspnea, run by University Medical Center Groningen at 1 site in Netherlands.
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 4 inclusion and 6 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 10 May 2024. 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 Netherlands. 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?
End-expiratory lung volume (time frame: Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep.). The study lists 4 primary outcomes in all. 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 10 May 2024.