CopdNCT04211038
Assessment of Neural Inspiratory Time Through sEMG and EMGdi
A study testing inspiratory threshold load device in people with Copd and Ventilation, run by Zhenfeng He at 1 site in China.
Trial summary
The onset and offset of the neural inspiratory time are fundamentally important measurements in studies of patientventilator interaction, where the level of assistance delivered by the ventilator is controlled by the patient's demand. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Copd, Ventilation, Rehabilitation
- What is being tested?
- inspiratory threshold load device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2019to 30 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal cardio-pulmonary function
- without low inspiratory muscle strength
- non-smoker
- without history of the nervous system and respiratory system disease
- sever to very severe stable stage
Who cannot join
- systemic application of corticosteroids nearly 4 weeks
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University.
Guangzhou, Guangdong
Zhenfeng He, MD, 8602083062882, zfHe_2019@163.com
About this study
Official title: Assessment of Neural Inspiratory Time Through Transesophageal and Surface Electromyography
The onset and offset of the neural inspiratory time are fundamentally important measurements in studies of patientventilator interaction, where the level of assistance delivered by the ventilator is controlled by the patient's demand. The onset of neural inspiratory time can be determined in esophageal pressure, transdiaphragmatic pressure, and EMG signals. The investigator compare the onset measured by EMG, esophageal and transdiaphragmatic pressure, and consider that the correlation between them is well in different conditions.
Read the detailed description
The onset and offset of the neural inspiratory time are fundamentally important measurements in studies of patien-tventilator interaction, where the level of assistance delivered by the ventilator is controlled by the patient's demand. Patient-ventilator asynchrony evaluated using the time lag between onset of the neural inspiratory time and the onset of a mechanical ventilation signal. The onset of neural inspiratory time can be determined in esophageal pressure, transdiaphragmatic pressure, and EMG signals. The investigator compare the onset measured by EMG, esophageal and transdiaphragmatic pressure, and consider that the correlation between them is well in three different conditions.
- Conditions
- Copd, Ventilation, Rehabilitation
- Being tested
- inspiratory threshold load device
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory threshold load deviceDevice
Also called cycle ergometer
Before experiment ,every subject use a flanged mouthpiece attached to a manually operated occlusion valve in order to measure maximal inspiratory pressure (MIP)at functional residual capacity .
And then, the healthy subjects will be increased the neural respiratory drive by increasing the pressure in a water-sealed inspiratory threshold loading device. At last, all subjects will do Incremental cycle ergometry test with the assisstance of NPPV.
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Experimental | Firstly, increase the inspiratory threshold load step by step(30%-80%MIP),in order to increase neural respiratory drive. Secondly, do incremental cycle ergometry test with the assisstance of NPPV. Receives: Device: inspiratory threshold load device |
| COPD subjects | Experimental | Firstly, increase the inspiratory threshold load step by step(30%-80%MIP),in order to increase neural respiratory drive. Secondly, do incremental cycle ergometry test with the assisstance of NPPV. Receives: Device: inspiratory threshold load device |
What is being measured
The primary outcome is the main question the study is designed to answer.
the onset and duration of neural inspiratory time
Correlation between onsets and duration of measured from espphageal pressure, transdiaphragmatie pressure and EMG.
Measured: through study completion, an average of 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start27 Dec 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhenfeng He
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Medical University
- Responsible party
- Sponsor-investigator, Zhenfeng He, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211038
- Sponsor's protocol ID
- GIRH-201278
- Status last verified
- Feb 2021
- First submitted
- 22 Dec 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Neural Inspiratory Time Through Transesophageal and Surface Electromyography
- ClinicalTrials.gov ID
- NCT04211038
- Acronym / sponsor ID
- GIRH-201278
- Conditions
- Copd, Ventilation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhenfeng HeUniversity, hospital or other
- Collaborators
- Guangzhou Medical University
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 26 Dec 2019 (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.
The onset and offset of the neural inspiratory time are fundamentally important measurements in studies of patientventilator interaction, where the level of assistance delivered by the ventilator is controlled by the patient's demand. The onset of neural inspiratory time can be determined in esophageal pressure, transdiaphragmatic pressure, and EMG signals. The investigator compare the onset measured by EMG, esophageal and transdiaphragmatic pressure, and consider that the correlation between them is well in different conditions.
Detailed description
The onset and offset of the neural inspiratory time are fundamentally important measurements in studies of patien-tventilator interaction, where the level of assistance delivered by the ventilator is controlled by the patient's demand. Patient-ventilator asynchrony evaluated using the time lag between onset of the neural inspiratory time and the onset of a mechanical ventilation signal. The onset of neural inspiratory time can be determined in esophageal pressure, transdiaphragmatic pressure, and EMG signals. The investigator compare the onset measured by EMG, esophageal and transdiaphragmatic pressure, and consider that the correlation between them is well in three different conditions.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | Experimental | Device: inspiratory threshold load deviceFirstly, increase the inspiratory threshold load step by step(30%-80%MIP),in order to increase neural respiratory drive. Secondly, do incremental cycle ergometry test with the assisstance of NPPV. |
| COPD subjects | Experimental | Device: inspiratory threshold load deviceFirstly, increase the inspiratory threshold load step by step(30%-80%MIP),in order to increase neural respiratory drive. Secondly, do incremental cycle ergometry test with the assisstance of NPPV. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- normal cardio-pulmonary function
- without low inspiratory muscle strength
- non-smoker
- without history of the nervous system and respiratory system disease
- sever to very severe stable stage
Key exclusion criteria (1 listed)
- systemic application of corticosteroids nearly 4 weeks
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 |
|---|---|---|
| inspiratory threshold load deviceAlso: cycle ergometerBefore experiment ,every subject use a flanged mouthpiece attached to a manually operated occlusion valve in order to measure maximal inspiratory pressure (MIP)at functional residual capacity . And then, the healthy subjects will be increased the neural respiratory drive by increasing the pressure in a water-sealed inspiratory threshold loading device. At last, all subjects will do Incremental cycle ergometry test with the assisstance of NPPV. | Device | COPD subjects, healthy subjects |
Primary outcome
the onset and duration of neural inspiratory time
Time frame: through study completion, an average of 5 hours
Correlation between onsets and duration of measured from espphageal pressure, transdiaphragmatie pressure and EMG.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory threshold load device in people with Copd and Ventilation, run by Zhenfeng He at 1 site in China.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Feb 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenfeng He (+8613678935748, zfhe_2019@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the onset and duration of neural inspiratory time (time frame: through study completion, an average of 5 hours). 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 23 Feb 2021.