Clinical trial NCT05880264: Development of Standard References of Maximal Inspiratory Pressure and Maximal Expiratory Pressure in Healthy Adults
Official title: Development of Standard References of Maximal Inspiratory Pressure and Maximal Expiratory Pressure in Healthy Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Adults
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who are scheduled to surgery under general anesthesia at Yonsei University Severance Hospital.

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Measure MIP for healthy Koreans and obtain the reference value
timeFrame: up to 1 year
measure: Measure MEP for healthy Koreans and obtain the reference value.
timeFrame: up to 1 year
measure: Measure MVV for healthy Koreans and obtain the reference value.
timeFrame: up to 1 year
Secondary outcomes:
measure: Check the predictive equation (forced vital capacity)
timeFrame: up to 1 year
measure: Check the predictive equation (forced expiratory volume 1)
timeFrame: up to 1 year
measure: Check the predictive equation (FEV1/FVC)
timeFrame: up to 1 year
measure: Check the predictive equation (PEF)
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
name: HYO JIN BYON
role: PRINCIPAL_INVESTIGATOR
References: