The goal of this four-part preclinical \[I-II\] and clinical \[III-IV\] trial is to compare, with randomised crossover study design \[I-IV\], a new medical airway device with standard procedure (biteblock or no device) for upper airway patency during sedation with intravenous propofol \[I-IV\]. \- Page 1 of 9 \[DRAFT\] - The two main questions it aims to answer are if this new airway device is superior to standard procedure with respect to * maintenance of spontaneous ventilation \[I\] and upper airway volumes \[II\] at moderate and deep steady-state levels of sedation in healthy volunteer study participants, and * fewer and less lasting bedside signs of respiratory depression \[III-IV\], and less adjuvant use of manual airway support \[III-IV\] during procedural sedation (PS) according to standard of care(SOC) in study patients scheduled for colonoscopy or ureteral catheterisation under PS. Owing to the crossover study design used throughout the trial, there are no comparison groups of study participants \[I-II\] or study patients \[III-IV\].
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Difference in absolute and relative tidal volumes at deep sedation [I]
Timeframe: Estimated duration of measurements: 2-3 minutes per intervention. Estimated study period: 1-2 hours per participant.
Difference in absolute and relative MRI-derived anteroposterior transpharyngeal distances at deep sedation [II]
Timeframe: Estimated duration of measurements: 2-3 min per intervention. Estimated study period: 1.5-2.5 h per participant.
Difference in adjuvant use of manual airway support during PS according to SOC [III-IV].
Timeframe: Duration of measurements: 8 minutes per intervention. Estimated study period: 0.5-1 hours per patient.]