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Not yet recruitingNCT05880264Updated May 30, 2023

Development of Standard References of Maximal Inspiratory Pressure and Maximal Expiratory Pressure in Healthy Adults

An observational study in Healthy Adults, sponsored by Yonsei University. Not yet recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-30.

Sponsored by Yonsei University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2023, 3 years 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
19 Years to 65 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Healthy Adults
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's planned enrollment of 200 is above the median of 65 across 184 observational studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

People who are scheduled to surgery under general anesthesia at Yonsei University Severance Hospital.

Inclusion criteria

  1. 19 to 65 years old.
  2. a patient under general anesthesia
  3. Patients in ASA class I to II
  4. a patient with no history of thoracic anatomy or surgery
  5. Patients with normal chest X-ray findings for preoperative evaluation.

Exclusion criteria

Exclusion Criteria:

  1. Patients with no natural history of thoracic abnormalities or surgery
  2. Patients with asthma, pneumonia, tuberculosis, pneumothorax, chronic obstructive pulmonary disease and epileptic pulmonary disease
  3. Patients who have difficulty communicating with the examiner.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Measure MIP for healthy Koreans and obtain the reference value

    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.

    Time frame: up to 1 year

  2. Measure MEP for healthy Koreans and obtain the reference value.

    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.

    Time frame: up to 1 year

  3. Measure MVV for healthy Koreans and obtain the reference value.

    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.

    Time frame: up to 1 year

Secondary outcomes

  1. 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

    Time frame: up to 1 year

  2. 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

    Time frame: up to 1 year

  3. 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

    Time frame: up to 1 year

  4. 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

    Time frame: up to 1 year

07

Study locations

1 site
  • Severance hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05880264
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
May 30, 2023
Start date
Jun 2023 (estimated)
Primary completion
Jul 2023 (estimated)
Completion
Jul 2023 (estimated)
Last update
May 30, 2023

Study contacts

HYO JIN BYON
Contact
jinoben@naver.com
82-10-9134-1566
HYO JIN BYON
principal investigator · Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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