Comparative Evaluation of the Use of a Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry Measurements
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Politecnico di Milano
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- impedance measurements
Study Overview
Brief Summary
The study aims to evaluate the measurement accuracy of respiratory impedance during oscillometry (or Forced Oscillation Technique - FOT) under the following conditions: 1)The subject's cheeks are manually supported by an expert (Gold Standard method), 2) The subject's cheeks are supported by an integrated cheek support in the mouthpiece.
It is a prospective, randomized, cross-over study on Subjects who will present themselves at the offices of the participating doctors, aged between 5 and 75 years. The primary outcome is to Compare the respiratory impedance measurements under the two measurement conditions. Secondary Objectives are to: i)evaluate the patient's comfort during the measurement with the cheek support and compare this comfort to the gold standard condition; ii) assess the maximum and minimum face dimensions of the recruited subjects that allow for effective and comfortable cheek support; iii) evaluate the type and frequency of measurement errors introduced by the use of the integrated cheek support in the mouthpiece.
Detailed Description
Study design: prospective, randomized, cross-over study. Study population: Subjects who will present themselves at the participating doctors' offices. Inclusion criteria: subjects aged between 5 and 75 years. Exclusion criteria: Subjects unable to follow the study procedures or with any physical or mental condition deemed unsuitable by the doctor will be excluded from the study.
Study protocol: the measurement protocol will consist of measuring the subject's facial morphological parameters and respiratory impedance parameters, followed by the administration of a questionnaire on perceived comfort. The procedure will be performed in a seated position.
Measurements:
- Morphological Parameters Using a sliding caliper. The following anatomical distances will be measured on the seated subject, looking straight ahead with teeth together, facial muscles relaxed, and mouth closed: a) BIGONIAL WIDTH: The straight-line distance between the right and left angles of the mandible; b) LIP LENGTH: The straight-line distance between the right and left corners of the closed mouth."
- Respiratory Impedance. The impedance measurement will be performed using the Resmon FIRST (Restech srl, Milan, Italy). Repeated measurements will be taken for each subject three times (TRIPLICATE) over 10 breaths with mono-frequency oscillations at 5 Hz. The enrolled subjects will perform the following measurements in a random order:
- One TRIPLICATE session of respiratory impedance with cheeks supported by study personnel.
- One TRIPLICATE session of respiratory impedance with cheeks supported by the cheek support. The study personnel will record any operator errors associated with preparing and using the cheek support on the enrolled participants.
- Comfort Evaluation Questionnaire. At the end of the measurements, each participant will be asked to complete a comfort evaluation questionnaire regarding their experience during the procedure. Currently, no commercial devices are similar to the cheek support being tested. Therefore, the questionnaire is a modified version of a questionnaire previously used to evaluate the comfort of mechanical respirators worn on patients' faces during the coronavirus disease (COVID-19) period (Respirator Comfort, Wearing Experience, and Function Instrument (R-COMFI)3). The questionnaire aims to cover sensations of discomfort and general impressions of using the mouthpiece with cheek support during respiratory oscillometry measurements.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •subjects aged between 5 and 75 years
Exclusion Criteria
- •Subjects unable to follow the study procedures or with any physical or mental condition deemed unsuitable by the doctor will be excluded from the study
Outcomes
Primary Outcomes
impedance measurements
Time Frame: within session (about 15 min)
Compare the respiratory respiratory resistance (cmH2O\*s/L) and reactance (cmH2O\*s/L) at 5 Hz under the two measurement conditions
Secondary Outcomes
- evaluate patient's comfort during the measurement with the cheek support(within session (about 15 min))
- face dimensions allowing for effective and comfortable cheek support(within session (about 15 min))
- evaluate the type and frequency of measurement errors(within session (about 15 min))
Investigators
Raffaele Dellaca
professor
Politecnico di Milano