protocolSection identificationModule nctId: NCT06270212, orgStudyIdInfo id: CIV-ID 23-08-043797, briefTitle: Medical Device for Airway Patency During Sedation, acronym: STAIRWAY-2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Stairway Medical AB, class: INDUSTRY, collaborators name: Lund University, descriptionModule briefSummary: OVERALL SYNOPSISPART 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., conditionsModule conditions: Airway Obstruction, conditions: Sedation Complication, conditions: Perioperative Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Prospective randomized unpaired, and paired crossover, evaluations of study outcome measures in healthy volunteer study participants (PART A), and prospective randomized unpaired evaluation of study outcome measures in study patients (PART B).The number of arms reported below (3) refers to unpaired comparisons (PARTS A-B)., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: For practical reasons, study participants, sedationists and study investigators on site cannot be masked to study interventions.However, procedural interventionists on site and study investigators scrutinizing study outcome data will be masked to study interventions.The number of enrolled study participants reported below (46) refers to evaluable ones., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: STAIRWAY, interventions name: NO DEVICE, outcomesModule primaryOutcomes measure: Transpharyngeal distance during moderate-to-deep steady-state sedation., primaryOutcomes measure: Duration of manual airway support during PS for clinical procedures., secondaryOutcomes measure: Transpharyngeal distance during mild steady-state sedation., secondaryOutcomes measure: Duration of interrupted capnometric monitoring during sedation., secondaryOutcomes measure: Duration of manual airway support during induction of steady-state sedation., secondaryOutcomes measure: Sedational comfort, secondaryOutcomes measure: Conditions for sedation, secondaryOutcomes measure: Conditions for procedural intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Skåne University Hospital, status: RECRUITING, city: Malmö, state: Skåne, zip: 20502, country: Sweden, contacts name: Magnus Ljungvall, MD, role: CONTACT, phone: +46-705445502, email: magnus.ljungvall@med.lu.se, contacts name: Jonas Åkeson, PhD, Professor, role: CONTACT, phone: +46-708311113, email: jonas.akeson@med.lu.se, geoPoint lat: 55.60587, lon: 13.00073, hasResults: False