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

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05880264
• Other study ID #: 4-2022-0745
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: July 2023

Study information

• Verified date: May 2023
• Source: Yonsei University
• Contact: HYO JIN BYON
• Phone: 82-10-9134-1566
• Email: jinoben[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adults
• Respiratory Aspiration

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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