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

(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 Overview

• Status: Not yet recruiting
• Conditions: Healthy Adults

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: HYO JIN BYON; Phone Number: 82-10-9134-1566; Email: jinoben@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital
    • Contact: HYO JIN BYON; Phone Number: 82-2-2228-0557; Email: jinoben@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 1 year
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.	up to 1 year
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.	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	up to 1 year

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: HYO JIN BYON, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): July 1, 2023

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 4-2022-0745

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No