Evaluation of Medical Device for Airway Patency During Sedation (SW01-2022)

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 tomaintenance of spontaneous ventilation [I] and upper airway volumes [II] at moderate and deep steady-state levels of sedation in healthy volunteer study participants, andfewer 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].

INCLUSION CRITERIAParts I-II:Adult.No known allergy or hypersensitivity to drugs used for routine sedation or to ID materials (polypropylene or ethylene vinylacetate).Healthy with no medical comorbidity according to physician's judgement and physical examination.No cognitive or psychosocial distress.Complete or partial dentation.No mobile teeth or reconstructions.No orthodontic braces.Non-pregnant.Not breastfeeding.Ability to communicate in Swedish.No in situ magnetic device or implant [II].Oral and written informed consent to inclusion as healthy volunteer study participant.Parts III-IV:Adult scheduled for elective colonoscopy [III] or ureteral catheterisation [IV] under procedural sedation with propofol.No known allergy or hypersensitivity to drugs used for routine sedation or to ID materials (polypropylene or ethylene vinylacetate) in the ID.Comorbidity ASA class I-III.No cognitive or psychosocial distress.Complete or partial dentation.No mobile teeth or reconstructions.No orthodontic braces.Non-pregnant.Not breastfeeding.Ability to communicate in Swedish.Oral and written informed consent to inclusion as study participant.EXCLUSION CRITERIAParts I-IV:Withdrawal of informed consent.Suspected or manifest unforeseen allergic reaction.Inability to obtain enough relevant study data for medical or technical reasons.