COPDEMGNIVNCT03373175
Assesment of Muscular Unloading in Chronic Obstructive Pulmonary Disease (COPD) Patients With NIV
A study testing Basal record, PS 10 record and PS 15 record in people with COPD, run by Corporacion Parc Tauli at 2 sites in Spain.
Trial summary
Evaluation of high intensity NIMV in terms of physiological parameters has been performed in short-term studies in COPD patients. However, the support pressure levels used in exacerbated patients seem contradictory and the muscular unloading levels are uncertain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Basal record, PS 10 record and PS 15 record
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesSpain
- Study dates
- 30 Nov 2017to 3 May 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with COPD diagnoses based on a spirometry performed the previous year during stability.
- COPD patients with home NIV treatment of at least 6 months with acceptable compliance and adaptation.
- Stable patients or just before hospital discharge due to an exacerbation with gasometric stability.
Who cannot join
- Respiratory acidosis in blood gas analysis, just in case of recent exacerbation
- Patients with restrictive pathology and /or obesity (IMC>35)
- Poor quality of EMG signals.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Parc Tauli
Sabadell, Barcelona, 08208
About this study
Official title: Influence of Ventilator Model and Pressure Support Level in Muscular Unloading in COPD Patients With Non Invasive Ventilation (NIV)
Evaluation of high intensity NIMV in terms of physiological parameters has been performed in short-term studies in COPD patients. However, the support pressure levels used in exacerbated patients seem contradictory and the muscular unloading levels are uncertain. The objective of study is to determine the discharge level of the inspiratory musculature reached at the same pressure support (PS) values in a group of hospital and domiciliary ventilators. Patients with COPD in at least 6 months of treatment with home NIMV and in stable phase of their disease will be included. Eight commercial ventilators will be used, each patient will use 2 different ventilators. A 5 minute record will be taken at baseline (without NIMV). Subsequently, 5 minutes in NIMV in 3 levels of PS (15/10/20) for each ventilator (15/10/20) and patient with expiratory positive airway pressure (EPAP) of 5 centimeters of water (cmH2O) will be recorded. The results will be compared between the different ventilators and PS values using a general linear model for repeated variables to determine the differences between ventilators and PS levels of respiratory muscular unloading in COPD patients
- Conditions
- COPD
- Being tested
- Basal record, PS 10 record, PS 15 record, PS 20 record
- Keywords
- Monitoring NIV, inspiratory muscular unloading, EMG
- 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.
Basal recordDevice
Basal EMG record will be performed during 5 minutes. This record must be the same in both ventilators.
PS 10 recordDevice
PS 10 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record
PS 15 recordDevice
PS 15 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record
PS 20 recordDevice
PS 20 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record
| Study group | Role | What they receive |
|---|---|---|
| Ventilator 1 vs Ventilator 2 | Experimental | 2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed. Interventions: Basal record Pressure Support 10 (PS 10)record Pressure Support 15 (PS 15) record Pressure Support 20 (PS 20) record Receives: Device: Basal record; Device: PS 10 record; Device: PS 15 record; Device: PS 20 record |
| Ventilator 3 vs Ventilator 4 | Experimental | 2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed.Interventions: Basal record PS10 record PS15 record PS 20 record Receives: Device: Basal record; Device: PS 10 record; Device: PS 15 record; Device: PS 20 record |
| Ventilator 5 vs Ventilator 6 | Experimental | 2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed. Interventions: Basal record PS10 record PS15 record PS 20 record Receives: Device: Basal record; Device: PS 10 record; Device: PS 15 record; Device: PS 20 record |
| Ventilator 7 vs Ventilator 8 | Experimental | 2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed. Interventions: Basal record PS10 record PS15 record PS 20 record Receives: Device: Basal record; Device: PS 10 record; Device: PS 15 record; Device: PS 20 record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscular unloading (µv)
Differences in parasternal electromyogram (EMG) signals interpretation between the record of ventilator 1 and ventilator 2.
Measured: 1 day
Secondary outcomes (7)
Baseline EMG (µv) record
Parasternal EMG signals interpretation before and without NIV. Spontaneous breathing record. The outcome measure inspiratory muscular effort of the patient in basal conditions.
Measured: 1 day
Pressure support 10 EMG (µv) record. V1
Parasternal EMG signals interpretation during first phase of NIV, in this case it will be programmed at 10 cmH2O os pressure support (PS) with Ventilator 1 during 5 minutes.
Measured: 1 day
Pressure support 15 EMG (µv) record. V1
Parasternal EMG signals interpretation during the second phase of NIV that will be programmed at 15 cmH2O os pressure support (PS) with Ventilator 1 during 5 minutes
Measured: 1 day
Pressure support 20 EMG (µv) record. V1
Parasternal EMG signals interpretation during the last phase of NIV that will be programmed at 20 cmH2O os pressure support (PS) with Ventilator 1 during 5 minutes
Measured: 1 day
Pressure support 10 EMG (µv) record. V2
Paraesternal EMG signals interpretation during the last phase of NIV that will be programmed at 10 cmH2O os pressure support (PS) with Ventilator 2 during 5 minutes
Measured: 1 day
Pressure support 15 EMG (µv) record. V2
Parasternal EMG signals interpretation during the last phase of NIV that will be programmed at 15 cmH2O os pressure support (PS) with Ventilator 2 during 5 minutes
Measured: 1 day
Pressure support 20 EMG (µv) record. V2
Parasternal EMG signals interpretation during the last phase of NIV that will be programmed at 20 cmH2O os pressure support (PS) with Ventilator 2 during 5 minutes
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 posted14 Dec 2017
- Study start30 Nov 2017
- Primary completion30 Oct 2020
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manel Lujan-Torne, Corporacion Parc Tauli
- Investigators
- Manel Lujan, MD, Principal investigator, Corporacion Parc Tauli (Sabadell, Barcelona)Javier Sayas, Principal investigator, Hospital Universitario 12 de Octubre (Madrid)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373175
- Sponsor's protocol ID
- 2017632
- Acronym
- EMGNIV
- Status last verified
- Aug 2021
- First submitted
- 11 Dec 2017
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lalmolda C, Florez P, Corral M, Hernandez Voth A, Grimau C, Sayas J, Lujan M. Does the Efficacy of High Intensity Ventilation in Stable COPD Depend on the Ventilator Model? A Bench-to-Bedside Study. Int J Chron Obstruct Pulmon Dis. 2022 Jan 14;17:155-164. doi: 10.2147/COPD.S327994. eCollection 2022.
PubMed 35058690
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Ventilator Model and Pressure Support Level in Muscular Unloading in COPD Patients With Non Invasive Ventilation (NIV)
- ClinicalTrials.gov ID
- NCT03373175
- Acronym / sponsor ID
- EMGNIV / 2017632
- Conditions
- COPD
- Keywords
- Monitoring NIV, inspiratory muscular unloading, EMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 14 Dec 2017 (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.
Evaluation of high intensity NIMV in terms of physiological parameters has been performed in short-term studies in COPD patients. However, the support pressure levels used in exacerbated patients seem contradictory and the muscular unloading levels are uncertain. The objective of study is to determine the discharge level of the inspiratory musculature reached at the same pressure support (PS) values in a group of hospital and domiciliary ventilators. Patients with COPD in at least 6 months of treatment with home NIMV and in stable phase of their disease will be included. Eight commercial ventilators will be used, each patient will use 2 different ventilators. A 5 minute record will be taken at baseline (without NIMV). Subsequently, 5 minutes in NIMV in 3 levels of PS (15/10/20) for each ventilator (15/10/20) and patient with expiratory positive airway pressure (EPAP) of 5 centimeters of water (cmH2O) will be recorded. The results will be compared between the different ventilators and PS values using a general linear model for repeated variables to determine the differences between ventilators and PS levels of respiratory muscular unloading in COPD patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ventilator 1 vs Ventilator 2 | Experimental | Device: Basal record, Device: PS 10 record, Device: PS 15 record, Device: PS 20 record2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed. Interventions: Basal record Pressure Support 10 (PS 10)record Pressure Support 15 (PS 15) record Pressure Support 20 (PS 20) record |
| Ventilator 3 vs Ventilator 4 | Experimental | Device: Basal record, Device: PS 10 record, Device: PS 15 record, Device: PS 20 record2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed.Interventions: Basal record PS10 record PS15 record PS 20 record |
| Ventilator 5 vs Ventilator 6 | Experimental | Device: Basal record, Device: PS 10 record, Device: PS 15 record, Device: PS 20 record2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed. Interventions: Basal record PS10 record PS15 record PS 20 record |
| Ventilator 7 vs Ventilator 8 | Experimental | Device: Basal record, Device: PS 10 record, Device: PS 15 record, Device: PS 20 record2 Ventilators will be evaluated for patient. All parameters will be monitored and the differences will be analyzed. Interventions: Basal record PS10 record PS15 record PS 20 record |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with COPD diagnoses based on a spirometry performed the previous year during stability.
- COPD patients with home NIV treatment of at least 6 months with acceptable compliance and adaptation.
- Stable patients or just before hospital discharge due to an exacerbation with gasometric stability.
Key exclusion criteria (3 listed)
- Respiratory acidosis in blood gas analysis, just in case of recent exacerbation
- Patients with restrictive pathology and /or obesity (IMC>35)
- Poor quality of EMG signals.
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 |
|---|---|---|
| Basal recordBasal EMG record will be performed during 5 minutes. This record must be the same in both ventilators. | Device | Ventilator 1 vs Ventilator 2, Ventilator 3 vs Ventilator 4, Ventilator 5 vs Ventilator 6, Ventilator 7 vs Ventilator 8 |
| PS 10 recordPS 10 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record | Device | Ventilator 1 vs Ventilator 2, Ventilator 3 vs Ventilator 4, Ventilator 5 vs Ventilator 6, Ventilator 7 vs Ventilator 8 |
| PS 15 recordPS 15 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record | Device | Ventilator 1 vs Ventilator 2, Ventilator 3 vs Ventilator 4, Ventilator 5 vs Ventilator 6, Ventilator 7 vs Ventilator 8 |
| PS 20 recordPS 20 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record | Device | Ventilator 1 vs Ventilator 2, Ventilator 3 vs Ventilator 4, Ventilator 5 vs Ventilator 6, Ventilator 7 vs Ventilator 8 |
Primary outcome
Inspiratory muscular unloading (µv)
Time frame: 1 day
Differences in parasternal electromyogram (EMG) signals interpretation between the record of ventilator 1 and ventilator 2.
7 secondary outcomes
Baseline EMG (µv) record
Time frame: 1 day
Pressure support 10 EMG (µv) record. V1
Time frame: 1 day
Pressure support 15 EMG (µv) record. V1
Time frame: 1 day
Pressure support 20 EMG (µv) record. V1
Time frame: 1 day
Pressure support 10 EMG (µv) record. V2
Time frame: 1 day
Pressure support 15 EMG (µv) record. V2
Time frame: 1 day
Pressure support 20 EMG (µv) record. V2
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 4 Aug 2021.
- Derived from this study: PubMed 35058690Lalmolda C, Florez P, Corral M, Hernandez Voth A, Grimau C, Sayas J, Lujan M. Does the Efficacy of High Intensity Ventilation in Stable COPD Depend on the Ventilator Model? A Bench-to-Bedside Study. Int J Chron Obstruct Pulmon Dis. 2022 Jan 14;17:155-164. doi: 10.2147/COPD.S327994. eCollection 2022.
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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.
Manel Lujan, MD principal investigator
Corporacion Parc Tauli (Sabadell, Barcelona)
Javier Sayas principal investigator
Hospital Universitario 12 de Octubre (Madrid)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basal record, PS 10 record and PS 15 record in people with COPD, run by Corporacion Parc Tauli at 2 sites in Spain.
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 3 inclusion and 3 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 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Inspiratory muscular unloading (µv) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373175, which also lists 1 linked publication.
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 4 Aug 2021.