TCTR20230927004Not yet recruitingNot Applicable
Comparison of spirometry parameters between face mask and flanged mouthpiece interface in normal subjects and patients with facial muscle weakness
/A0 sites64 target enrollmentStarted: September 27, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 64
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to N/A (No limit) (—)
- Sex
- All
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.
Investigators
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