Evaluation of Medical Device for Airway Patency During Sedation (SW01-2022) (NCT05708651) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of Medical Device for Airway Patency During Sedation (SW01-2022)
56 participantsStarted 2023-02
Plain-language summary
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 \[III-IV\].
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA
Parts 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 CRITERIA
Parts I-IV:
Withdrawal of informed consent.
Suspected or manifest unforeseen allergic reaction.
Inability to obtain enough relevant study data for medical or technical reasons.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
2
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.
3
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.]