Clinical Research Directory

Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry

Sponsor: Politecnico di Milano

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.

Official title: Comparative Evaluation of the Use of a Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry Measurements

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Interventions

Locations (1)