Pulmonary Disease, Chronic ObstructiveHFNIVNCT04597606

Respiratory Drive Response in COPD Patients During Exercise With Non Invasive Ventilation (NIV).

An observational study of Pulmonary Disease, Chronic Obstructive, run by Javier Sayas Catalan at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Exercise with spontaneous ventilation., Exercise with NIV and Exercise with HFNC
Type of treatment: Medical device
How many people: 12 participants
Where: 1 siteSpain
Study dates: 2 Sep 2019to 15 Nov 2022
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 recluted from the pneumology outpatient clinic of the Hospital 12 de Octubre

Who may be able to join

Patients with severe COPD or cystic fibrosis (with an obstructive pattern and air trapping) on the waiting list for a lung transplant, assessed by the Lung Transplant Unit of the 12 de Octubre University Hospital.
Diagnostic criteria for COPD according to the GOLD and residual volume greater than 120% of theoretical
Evidence of developing dynamic air trapping by analyzing flow / volume curves during physical exercise.
Patients already adapted to home noninvasive mechanical ventilation (NIV) waiting for transplantation.

Who cannot join

Presence of comorbidities that limit the patient's physical effort capacity (uncontrolled ischemic heart disease, severe pulmonary hypertension, neuromuscular disease).
Refusal of treatment with NIV, or inclusion in the study.
Inability to perform the proposed exercise in basal conditions and with ventilation.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Javier Sayas Catalan
Madrid, 28041

Other trials in Spain

About this study

Official title: Non-Invasive Ventilation (NIV) Effect on Neurorespiratory Coupling in Chronic Obstructive Pulmonary Disease During Exercise (COPD).

A constant load exercise during 10 minutes will be performed in a group of Chronic Obstructive Pulmonary Disease patients, in a basal condition (spontaneous breathing); under noninvasive mask ventilation and with high flow nasal cannula. With the aim of reducing dyspnea, increasing exercise tolerance, and unload respiratory muscles, three exercises will be compared in terms of use of respiratory muscles and neural drive measured with paraesternal electromyography.

Read the detailed description

Exercise in chronic obstructive pulmonary disease is limited by dynamic hyperinflation and respiratory muscle overloadleading to severe dyspnea. During exercise, the increase in neural respiratory drive is notable to match ventilatory demand, correlated with breathlessness. Non-Invasive Ventilation may improve neural respiratory drive uncoupling and exercise tolerance. The aim of this study will be prove if Non-Invasive Ventilation and High flow nasal cannula during exercise reduces neural respiratory drive and improves dyspnea, measured with paraesternal electromyography

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Exercise with spontaneous ventilation., Exercise with NIV, Exercise with HFNC
Keywords: Noninvasive Ventilation, Exercise
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exercise with spontaneous ventilation.Other
Patients will perform 10 minutes, constant load, exercise in a cycloergometer. To set the load, a baseline incremental effort test will be performed previously (VISIT 1).
Then, in a separate day (VISIT 2), the subject will perform 10 minutes cycling at the 75% load of that determined as maximum in VISIT 1, at a constant rate of 30 to 35 pedal revolutions per minute, in spontaneous breathing, with low flow oxygen through conventional nasal cannula adjusted to achieve SpO2 between 92to 94%
Exercise with NIVDevice
VISIT 2 Non invasive mask ventilation: parameters will be titrated during a free cycling period at the end of the spontaneous breathing exercise. Then, in a separate day (VISIT 3), with the same constant load, cycling cadence and under NIV, the patient will perform 10 min of cycling.
Exercise with HFNCDevice
With constant flows of 50 lpm and with FiO2 adjusted according to SPO2, to obtain a constant saturation between 92 and 94%. The same pedaling load and frequency will be maintained, with similar variables collected.

Study groups in NCT04597606
Study group	Role	What they receive
Cohort		All patients will be performed a basal test that consist on continuous cyclergometer exercise, under constant load, with spontaneous breathing, after that the same exercise protocol performed will be carried out under non-invasive ventilation (NIV test). Parameters will be titrated previosuly. Finally the patient will perform the same exercise at a constant load under high flow oxygen therapy ( HFNC test). Receives: Other: Exercise with spontaneous ventilation.; Device: Exercise with NIV; Device: Exercise with HFNC

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Neural ventilator (NVU) (%)
the peak value (on the baseline) of the maximum muscle activity ( Root mean square EMG value in mV), both diaphragmatic (EMGDimax) and parasternal (EMGparamax) in the máximum intentional ventilation and maximum inspiratory peak (MIP) will be taken. This value will be consider 100% and based on this mean EMG will be calculate for a normalized EMGdi (RMS) and paraesternal in each ventilatory situation (spontaneous ventilation or under NIV). At each effort point (in each minute of the exercise protocol), the relationship between the normalized EMG value (parasternal and Diaphragmatic) and the tidal volume (obtained by integral of flow signal by means of a pneumotachograph connected to the VM -in NIV- or oronasal hermetic mask -in Vesp). To facilitate the interpretation of the expired TV, the mask without leakage will be used with the intentional leak connected in the circuit, before the pneumotachograph.
Measured: 24 hours, 48 hours, 72 hours

Secondary outcomes (17)

Borg Scale Dyspnea evolution (points)
Degree of dyspnea will be determined by this validated scale with a result between 1 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum
Measured: Basal value at day 1 and every 60 seconds during the exercise
Borg Scale Dyspnea evolution (points)
Degree of dyspnea will be determined by this validated scale with a result between 1 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum
Measured: 24 hours later than day 1 (day 2) during the exercise every 60 seconds
Borg Scale Dyspnea evolution (points)
Degree of dyspnea will be determined by this validated scale with a result between 1 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum
Measured: 48 hours later than day 1 (day 3) during the exercise every 60 seconds
Borg Scale Dyspnea evolution (points)
Degree of dyspnea will be determined by this validated scale with a result between 1 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum
Measured: 72 hours later than day 1 (day 4) during the exercise every 60 seconds
Transcutaneous pCO2 Final - inicial (mmHg)
Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2)
Measured: Basal value at day 1 during the exercise
Transcutaneous pCO2 Final - inicial (mmHg)
Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2)
Measured: During the exercise at day 2 ( 24 hours later than day 1)
Transcutaneous pCO2 Final - inicial (mmHg)
Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2)
Measured: During the exercise at day 3 (48 hours later than day 1)
Transcutaneous pCO2 Final - inicial (mmHg)
Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2)
Measured: During the exercise at day 4 (72 hours later than day 1 )
Total Training time (pedaling, minutes)
Total Time that the patient remains pedaling
Measured: During the exercise at day 2 ( 24 hours later than day 1)
Total Training time (pedaling, minutes)
Total Time that the patient remains pedaling
Measured: During the exercise at day 3 ( 48 hours later than day 1)
Total Training time (pedaling, minutes)
Total Time that the patient remains pedaling
Measured: During the exercise at day 4 ( 72 hours later than day 1)
Stops (n)
Number of stops that the patient performs during the test
Measured: During the exercise at day 2 ( 24 hours later than day 1)
Stops (n)
Number of stops that the patient performs during the test
Measured: During the exercise at day 3 ( 48 hours later than day 1)
Stops (n)
Number of stops that the patient performs during the test
Measured: During the exercise at day 4 ( 72 hours later than day 1)
Ineffective efforts %
Porcentage of ineffective efforts during the exercise
Measured: During the exercise at day 2 ( 24 hours later than day 1)
Ineffective efforts %
Porcentage of ineffective efforts during the exercise
Measured: During the exercise at day 3 ( 48 hours later than day 1)
Ineffective efforts %
Porcentage of ineffective efforts during the exercise
Measured: During the exercise at day 4 ( 72 hours later than day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 201915 Nov 2022

First posted22 Oct 2020
Study start2 Sep 2019
Primary completion15 Nov 2022
Study completion15 Nov 2022

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 Pulmonary Disease, Chronic ObstructiveStudies 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: Cohort
Time perspective: Prospective
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04597606
Sponsor's protocol ID: NIV and HFNC EXERCISE COPD
Acronym: HFNIV
Status last verified: Nov 2022
First submitted: 18 Sep 2020
Last updated: 23 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sayas J, Lalmolda C, Corral M, Florez P, Hernandez-Voth A, Janssens JP, Rabec C, Langevin B, Lofaso F, Carlucci A, Llontop C, Winck JC, Bermejo JG, Lujan M. Measurement of thoraco-abdominal synchrony using respiratory inductance plethysmography: technical aspects and a proposal to overcome its limitations. Expert Rev Respir Med. 2024 Mar-Apr;18(3-4):227-236. doi: 10.1080/17476348.2024.2363058. Epub 2024 Jun 7.
PubMed 38829281

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Invasive Ventilation (NIV) Effect on Neurorespiratory Coupling in Chronic Obstructive Pulmonary Disease During Exercise (COPD).
ClinicalTrials.gov ID: NCT04597606
Acronym / sponsor ID: HFNIV / NIV and HFNC EXERCISE COPD
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Noninvasive Ventilation, Exercise
Study type: Observational
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Javier Sayas CatalanUniversity, hospital or other
Study start: 2 Sep 2019 (actual)
Primary completion: 15 Nov 2022 (actual)
Study completion: 15 Nov 2022 (actual)
First posted: 22 Oct 2020 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cohort	–	Other: Exercise with spontaneous ventilation., Device: Exercise with NIV, Device: Exercise with HFNCAll patients will be performed a basal test that consist on continuous cyclergometer exercise, under constant load, with spontaneous breathing, after that the same exercise protocol performed will be carried out under non-invasive ventilation (NIV test). Parameters will be titrated previosuly. Finally the patient will perform the same exercise at a constant load under high flow oxygen therapy ( HFNC test).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients will be recluted from the pneumology outpatient clinic of the Hospital 12 de Octubre

Key inclusion criteria (4 listed)

Patients with severe COPD or cystic fibrosis (with an obstructive pattern and air trapping) on the waiting list for a lung transplant, assessed by the Lung Transplant Unit of the 12 de Octubre University Hospital.
Diagnostic criteria for COPD according to the GOLD and residual volume greater than 120% of theoretical
Evidence of developing dynamic air trapping by analyzing flow / volume curves during physical exercise.
Patients already adapted to home noninvasive mechanical ventilation (NIV) waiting for transplantation.

Key exclusion criteria (3 listed)

Presence of comorbidities that limit the patient's physical effort capacity (uncontrolled ischemic heart disease, severe pulmonary hypertension, neuromuscular disease).
Refusal of treatment with NIV, or inclusion in the study.
Inability to perform the proposed exercise in basal conditions and with ventilation.

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
Exercise with spontaneous ventilation.Patients will perform 10 minutes, constant load, exercise in a cycloergometer. To set the load, a baseline incremental effort test will be performed previously (VISIT 1). Then, in a separate day (VISIT 2), the subject will perform 10 minutes cycling at the 75% load of that determined as maximum in VISIT 1, at a constant rate of 30 to 35 pedal revolutions per minute, in spontaneous breathing, with low flow oxygen through conventional nasal cannula adjusted to achieve SpO2 between 92to 94%	Other	Cohort
Exercise with NIVVISIT 2 Non invasive mask ventilation: parameters will be titrated during a free cycling period at the end of the spontaneous breathing exercise. Then, in a separate day (VISIT 3), with the same constant load, cycling cadence and under NIV, the patient will perform 10 min of cycling.	Device	Cohort
Exercise with HFNCWith constant flows of 50 lpm and with FiO2 adjusted according to SPO2, to obtain a constant saturation between 92 and 94%. The same pedaling load and frequency will be maintained, with similar variables collected.	Device	Cohort

Primary outcome

Changes in Neural ventilator (NVU) (%)
Time frame: 24 hours, 48 hours, 72 hours
the peak value (on the baseline) of the maximum muscle activity ( Root mean square EMG value in mV), both diaphragmatic (EMGDimax) and parasternal (EMGparamax) in the máximum intentional ventilation and maximum inspiratory peak (MIP) will be taken. This value will be consider 100% and based on this mean EMG will be calculate for a normalized EMGdi (RMS) and paraesternal in each ventilatory situation (spontaneous ventilation or under NIV). At each effort point (in each minute of the exercise protocol), the relationship between the normalized EMG value (parasternal and Diaphragmatic) and the tidal volume (obtained by integral of flow signal by means of a pneumotachograph connected to the VM -in NIV- or oronasal hermetic mask -in Vesp). To facilitate the interpretation of the expired TV, the mask without leakage will be used with the intentional leak connected in the circuit, before the pneumotachograph.

17 secondary outcomes

Borg Scale Dyspnea evolution (points)
Time frame: Basal value at day 1 and every 60 seconds during the exercise
Borg Scale Dyspnea evolution (points)
Time frame: 24 hours later than day 1 (day 2) during the exercise every 60 seconds
Borg Scale Dyspnea evolution (points)
Time frame: 48 hours later than day 1 (day 3) during the exercise every 60 seconds
Borg Scale Dyspnea evolution (points)
Time frame: 72 hours later than day 1 (day 4) during the exercise every 60 seconds
Transcutaneous pCO2 Final - inicial (mmHg)
Time frame: Basal value at day 1 during the exercise
Transcutaneous pCO2 Final - inicial (mmHg)
Time frame: During the exercise at day 2 ( 24 hours later than day 1)
Transcutaneous pCO2 Final - inicial (mmHg)
Time frame: During the exercise at day 3 (48 hours later than day 1)
Transcutaneous pCO2 Final - inicial (mmHg)
Time frame: During the exercise at day 4 (72 hours later than day 1 )
Total Training time (pedaling, minutes)
Time frame: During the exercise at day 2 ( 24 hours later than day 1)
Total Training time (pedaling, minutes)
Time frame: During the exercise at day 3 ( 48 hours later than day 1)
Total Training time (pedaling, minutes)
Time frame: During the exercise at day 4 ( 72 hours later than day 1)
Stops (n)
Time frame: During the exercise at day 2 ( 24 hours later than day 1)
Stops (n)
Time frame: During the exercise at day 3 ( 48 hours later than day 1)
Stops (n)
Time frame: During the exercise at day 4 ( 72 hours later than day 1)
Ineffective efforts %
Time frame: During the exercise at day 2 ( 24 hours later than day 1)
Ineffective efforts %
Time frame: During the exercise at day 3 ( 48 hours later than day 1)
Ineffective efforts %
Time frame: During the exercise at day 4 ( 72 hours later than day 1)

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 23 Nov 2022.
Derived from this study: PubMed 38829281Sayas J, Lalmolda C, Corral M, Florez P, Hernandez-Voth A, Janssens JP, Rabec C, Langevin B, Lofaso F, Carlucci A, Llontop C, Winck JC, Bermejo JG, Lujan M. Measurement of thoraco-abdominal synchrony using respiratory inductance plethysmography: technical aspects and a proposal to overcome its limitations. Expert Rev Respir Med. 2024 Mar-Apr;18(3-4):227-236. doi: 10.1080/17476348.2024.2363058. Epub 2024 Jun 7.
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.

Javier Sayas principal investigator

Hospital 12 de OCtubre

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 Pulmonary Disease, Chronic Obstructive, run by Javier Sayas Catalan at 1 site 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 4 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 23 Nov 2022. 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 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?

Changes in Neural ventilator (NVU) (%) (time frame: 24 hours, 48 hours, 72 hours). 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 NCT04597606, 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 23 Nov 2022.