Healthy AdultsNCT05880264
Development of Standard References of Maximal Inspiratory Pressure and Maximal Expiratory Pressure in Healthy Adults
An observational study of Healthy Adults, run by Yonsei University at 1 site in South Korea.
Trial summary
(1) Maximum respiratory pressure (MRP)1) Maximum inspiratory pressure (maximum intake pressure) and maximum expiratory pressure (MEP) Digital spirometer (Pony FX, COSMED Inc., Italy) are used to measure the micro-paste in a seated position. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Healthy Adults
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2023to Jul 2023
- 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 19 to 65 years
- All sexes
- Adult, Older adult
Study population: People who are scheduled to surgery under general anesthesia at Yonsei University Severance Hospital.
Who may be able to join
- 19 to 65 years old.
- a patient under general anesthesia
- Patients in ASA class I to II
- a patient with no history of thoracic anatomy or surgery
- Patients with normal chest X-ray findings for preoperative evaluation.
Who cannot join
- Patients with no natural history of thoracic abnormalities or surgery
- Patients with asthma, pneumonia, tuberculosis, pneumothorax, chronic obstructive pulmonary disease and epileptic pulmonary disease
- Patients who have difficulty communicating with the examiner.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance hospital
Seoul
HYO JIN BYON, 82-2-2228-0557, jinoben@naver.com
About this study
(1) Maximum respiratory pressure (MRP)1) Maximum inspiratory pressure (maximum intake pressure) and maximum expiratory pressure (MEP) Digital spirometer (Pony FX, COSMED Inc., Italy) are used to measure the micro-paste in a seated position. MIP is based on the pressure maintained for at least 1 second, inhaling or exhaling with maximum effort in the maximum exhalation state (=residual volume) and the maximum exhalation state (=total lung capacity). The maximum positive pressure value of the MEP and the minimum sound pressure value of the MIP are selected among the three or more attempts. 2) Using the MVV (maximum volitional ventilation) Digital spirometer (Pony FX, COSMED Inc., Italy) machine, repeat breathing deeply and quickly for 12 seconds while wearing a nose plug, and multiply it by 5 to obtain the L/min value. (2) Measure the values of the Pneumatic ventilation. · FVC (forced vital capacity): Total expiratory volume of one of the maximum effort gases · FEV1 (forced expiratory volume 1, effort expiratory volume): Ejected expiratory volume of the first second of the maximum effort expiratory volume (FEV1/FVC): FVC ratio, percentage of FVCs, and extraction of the FVC (excessive flow). PEF): Highest speed of effort opportunity
- Conditions
- Healthy Adults
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure MIP for healthy Koreans and obtain the reference value
- The subject sits on a chair and covers his nose with a nose plug. B. The patient prepares the test with the Pony Fx MIP/MEP spirometer connected filter in his mouth.
- After inhaling as much as possible, exhale strongly through the filter with maximum force.
- At this time, the assistant guides the patient from the side so that the patient can exhale with maximum force.
- Check the results and select a pressure that is maintained for at least 1 second.
- The minimum sound pressure value is selected by attempting the A~E process more than three times.
Measured: up to 1 year
Measure MEP for healthy Koreans and obtain the reference value.
- The subject sits on a chair and covers his nose with a nose plug. B. The patient prepares the test with the Pony Fx MIP/MEP spirometer connected filter in his mouth.
- Breathe out as much as you can, and then breathe in strongly through the filter with maximum force.
- At this time, the assistant guides the patient from the side to breathe in with maximum force.
- Check the results and select a pressure that is maintained for at least 1 second.
- The maximum positive pressure value is selected by trying the A~E process more than three times.
Measured: up to 1 year
Measure MVV for healthy Koreans and obtain the reference value.
- The subject sits on a chair and covers his nose with a nose plug. B. The patient prepares the test with the Pony Fx MIP/MEP spirometer connected filter in his mouth.
- Repeat deep and fast breathing for 12 seconds with the start of the test. D. At this time, the assistant looks at the result graph and guides the patient from the side to make the best effort until the end.
- Multiply the result for 12 seconds by 5 to obtain the L/min value of MVV.
Measured: up to 1 year
Secondary outcomes (4)
Check the predictive equation (forced vital capacity)
Measure the above values using a Pulmonary function test Digital spirometer (Pony FX, COSMED Inc., Italy) machine.
- FVC (forced vital capacity): Total expiratory volume of one of the maximum effort gases
- FEV1 (forced expiratory volume 1, effort expiratory volume): Ejected expiratory volume of the first second of the maximum effort expiratory volume (FEV1/FVC): FVC ratio, percentage of FVCs, and extraction of the FVC (excessive flow).
PEF): Highest speed of effort opportunity
Measured: up to 1 year
Check the predictive equation (forced expiratory volume 1)
Measure the above values using a Pulmonary function test Digital spirometer (Pony FX, COSMED Inc., Italy) machine.
- FVC (forced vital capacity): Total expiratory volume of one of the maximum effort gases
- FEV1 (forced expiratory volume 1, effort expiratory volume): Ejected expiratory volume of the first second of the maximum effort expiratory volume (FEV1/FVC): FVC ratio, percentage of FVCs, and extraction of the FVC (excessive flow).
PEF): Highest speed of effort opportunity
Measured: up to 1 year
Check the predictive equation (FEV1/FVC)
Measure the above values using a Pulmonary function test Digital spirometer (Pony FX, COSMED Inc., Italy) machine.
- FVC (forced vital capacity): Total expiratory volume of one of the maximum effort gases
- FEV1 (forced expiratory volume 1, effort expiratory volume): Ejected expiratory volume of the first second of the maximum effort expiratory volume (FEV1/FVC): FVC ratio, percentage of FVCs, and extraction of the FVC (excessive flow).
PEF): Highest speed of effort opportunity
Measured: up to 1 year
Check the predictive equation (PEF)
Measure the above values using a Pulmonary function test Digital spirometer (Pony FX, COSMED Inc., Italy) machine.
- FVC (forced vital capacity): Total expiratory volume of one of the maximum effort gases
- FEV1 (forced expiratory volume 1, effort expiratory volume): Ejected expiratory volume of the first second of the maximum effort expiratory volume (FEV1/FVC): FVC ratio, percentage of FVCs, and extraction of the FVC (excessive flow).
PEF): Highest speed of effort opportunity
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study startJun 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HYO JIN BYON, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880264
- Sponsor's protocol ID
- 4-2022-0745
- Status last verified
- May 2023
- First submitted
- 26 Mar 2023
- Last updated
- 30 May 2023
- 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 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Standard References of Maximal Inspiratory Pressure and Maximal Expiratory Pressure in Healthy Adults
- ClinicalTrials.gov ID
- NCT05880264
- Acronym / sponsor ID
- 4-2022-0745
- Conditions
- Healthy Adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 30 May 2023 (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.
(1) Maximum respiratory pressure (MRP)1) Maximum inspiratory pressure (maximum intake pressure) and maximum expiratory pressure (MEP) Digital spirometer (Pony FX, COSMED Inc., Italy) are used to measure the micro-paste in a seated position. MIP is based on the pressure maintained for at least 1 second, inhaling or exhaling with maximum effort in the maximum exhalation state (=residual volume) and the maximum exhalation state (=total lung capacity). The maximum positive pressure value of the MEP and the minimum sound pressure value of the MIP are selected among the three or more attempts. 2) Using the MVV (maximum volitional ventilation) Digital spirometer (Pony FX, COSMED Inc., Italy) machine, repeat breathing deeply and quickly for 12 seconds while wearing a nose plug, and multiply it by 5 to obtain the L/min value. (2) Measure the values of the Pneumatic ventilation. · FVC (forced vital capacity): Total expiratory volume of one of the maximum effort gases · FEV1 (forced expiratory volume 1, effort expiratory volume): Ejected expiratory volume of the first second of the maximum effort expiratory volume (FEV1/FVC): FVC ratio, percentage of FVCs, and extraction of the FVC (excessive flow). PEF): Highest speed of effort opportunity
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People who are scheduled to surgery under general anesthesia at Yonsei University Severance Hospital.
Key inclusion criteria (5 listed)
- 19 to 65 years old.
- a patient under general anesthesia
- Patients in ASA class I to II
- a patient with no history of thoracic anatomy or surgery
- Patients with normal chest X-ray findings for preoperative evaluation.
Key exclusion criteria (3 listed)
- Patients with no natural history of thoracic abnormalities or surgery
- Patients with asthma, pneumonia, tuberculosis, pneumothorax, chronic obstructive pulmonary disease and epileptic pulmonary disease
- Patients who have difficulty communicating with the examiner.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure MIP for healthy Koreans and obtain the reference value
Time frame: up to 1 year
A. The subject sits on a chair and covers his nose with a nose plug. B. The patient prepares the test with the Pony Fx MIP/MEP spirometer connected filter in his mouth. C. After inhaling as much as possible, exhale strongly through the filter with maximum force. D. At this time, the assistant guides the patient from the side so that the patient can exhale with maximum force. E. Check the results and select a pressure that is maintained for at least 1 second. F. The minimum sound pressure value is selected by attempting the A~E process more than three times.
Measure MEP for healthy Koreans and obtain the reference value.
Time frame: up to 1 year
A. The subject sits on a chair and covers his nose with a nose plug. B. The patient prepares the test with the Pony Fx MIP/MEP spirometer connected filter in his mouth. C. Breathe out as much as you can, and then breathe in strongly through the filter with maximum force. D. At this time, the assistant guides the patient from the side to breathe in with maximum force. E. Check the results and select a pressure that is maintained for at least 1 second. F. The maximum positive pressure value is selected by trying the A~E process more than three times.
Measure MVV for healthy Koreans and obtain the reference value.
Time frame: up to 1 year
A. The subject sits on a chair and covers his nose with a nose plug. B. The patient prepares the test with the Pony Fx MIP/MEP spirometer connected filter in his mouth. C. Repeat deep and fast breathing for 12 seconds with the start of the test. D. At this time, the assistant looks at the result graph and guides the patient from the side to make the best effort until the end. E. Multiply the result for 12 seconds by 5 to obtain the L/min value of MVV.
4 secondary outcomes
Check the predictive equation (forced vital capacity)
Time frame: up to 1 year
Check the predictive equation (forced expiratory volume 1)
Time frame: up to 1 year
Check the predictive equation (FEV1/FVC)
Time frame: up to 1 year
Check the predictive equation (PEF)
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- 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.
HYO JIN BYON principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
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 Healthy Adults, run by Yonsei University at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 30 May 2023. 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 South Korea. 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 HYO JIN BYON (82-10-9134-1566, jinoben@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure MIP for healthy Koreans and obtain the reference value (time frame: up to 1 year). The study lists 3 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 30 May 2023.