Comparison of spirometry parameters between face mask and flanged mouthpiece interface in normal subjects and patients with facial muscle weakness

• Conditions: Facial or bulbar muscle weakness and healthy volunteers.; Spirometry, Facemask, Flanged mouthpiece, Facial muscle weakness, Bulbar muscle weakness

• Registration Number: TCTR20230927004
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-27
• Study Completion: 2024-03-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Healthy volunteers group, ages more than 18 years old

Facial or bulbar muscle weakness patient group, 1. Ages more than 18 years old, 2. Have facial or bulbar muscle weakness disease like Bell's palsy, ALS, bulbar MG, GBS, supranuclear lesion stroke or brain stem stroke

Exclusion Criteria

Healthy volunteers
1. who cannot cooperate with the maneuver
, 2. who has relative contraindication for spirometry test like
due to increase intracranial/ intraocular/ sinus pressure e.g., cerebral aneurysm
or due to increase intrathoracic and abdominal pressure e.g., presence pneumothorax
or due to increase in myocardial demand or change in blood pressure e.g., acute MI with in 1 week
or Infection control issue e.g., active pulmonary TB, 3. Who has deformity of face that cannot apply facemask for testing. 4. Who cannot seal the mouthpiece with lips, 5.cardiovascular disease, 6.respiratory disease, 7. Underlying disease that take medicine

Facial or bulbar muscle weakness group
1. who cannot cooperate with the maneuver
, 2. who has relative contraindication for spirometry test like
due to increase intracranial/ intraocular/ sinus pressure e.g., cerebral aneurysm
or due to increase intrathoracic and abdominal pressure e.g., presence pneumothorax
or due to increase in myocardial demand or change in blood pressure e.g., acute MI with in 1 week
or Infection control issue e.g., active pulmonary TB, 3. Who has deformity of face that cannot apply facemask for testing.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Forced vital capacity 5 months Spirometer,forced expiratory volume in 1 second 5 months Spiremeter

Secondary Outcome Measures

Name	Time	Method
Slow vital capacity 5 months Spirometer,Maximum inspiratory pressure 5 months Respiratory pressure meter,Maximum expiratory pressure 5 months Respiratory pressure meter