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

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

Status
Unknown
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20230927004
Enrollment
64
Registered
2023-09-27
Start date
2023-11-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial or bulbar muscle weakness and healthy volunteers. Spirometry, Facemask, Flanged mouthpiece, Facial muscle weakness, Bulbar muscle weakness

Interventions

Healthy, facial or bulbar muscle weakness disease like Bell&#039
s palsy, ALS, bulbar MG, GBS, supranuclear lesion stroke or brain stem stroke
Diagnostic,Diagnostic
Healthy group,Facial or bulbar muscle weakness patients

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Forced vital capacity 5 months Spirometer,forced expiratory volume in 1 second 5 months Spiremeter

Secondary

MeasureTime frame
Slow vital capacity 5 months Spirometer,Maximum inspiratory pressure 5 months Respiratory pressure meter,Maximum expiratory pressure 5 months Respiratory pressure meter

Countries

Thailand

Contacts

Public ContactPailin Boonkaya

King Chulalongkorn Memorial Hospital

Pailin_duan@hotmail.com0958290571

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026