Medical Device for Airway Patency During Sedation

OVERALL SYNOPSIS PART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants * of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype (STAIRWAY) vs. standard procedure (no device) during target-controlled induction of mild and moderate-to-deep sedation with propofol in the supine position * of minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels, determined by magnetic resonance imaging (MRI) with STAIRWAY vs. biteblock or no device during no, mild and moderate-to-deep steady-state sedation with propofol in the supine position. PART B: Systematic evaluation (in the body position \[normally supine\] considered most optimal for the procedural intervention) of the cumulative duration * of adjuvant manual airway support and ventilation * of respiratory arrest (interrupted monitoring of endtidal carbon dioxide \[ETCO2\]) * of hypoxemia (hemoglobin saturation of oxygen \[SpO2\] \<95 %), and * of perceived sedational comfort, of sedational and procedural usability, and of sedational and procedural preference with STAIRWAY vs. standard procedure (biteblock or no device) during PS according to SOC for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in spontaneously breathing study patients.