Medical Device for Airway Patency During Sedation

Launched by STAIRWAY MEDICAL AB · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called STAIRWAY, designed to keep the airway open during sedation, which is often needed for certain medical procedures. The trial has two parts: in the first part, healthy volunteers will help researchers compare how well the STAIRWAY device works against standard methods for maintaining airway patency during mild to deep sedation. In the second part, patients scheduled for procedures requiring sedation will use the device to see if it makes breathing easier and improves comfort during the process.

To participate, individuals must be between 18 and 65 years old, in good health, and able to communicate in Swedish. They should not have allergies to the sedation medications or materials used in the device, and they should have a complete set of teeth without any dental issues. Participants can expect to undergo sedation safely while helping researchers understand how well this new device performs compared to traditional methods. It's important to note that informed consent is required, and those who experience severe allergic reactions or cannot provide sufficient data for the study will be excluded.

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• • PART A: Adult (18-65 years). No known allergy or hypersensitivity to drugs used for routine sedation or to materials (PP or EVA) comprising STAIRWAY. Medically healthy with no comorbidity according to careful investigation by senior anaesthesiologist in charge of the sedation. No in situ magnetic device or implant. No cognitive or psychosocial distress, particularly including claustrofobia. Complete dentation. No mobile teeth, mobile reconstructions or orthodontic braces. Non-pregnant. No ongoing breast-feeding. Ability to communicate in Swedish. Oral and written informed consent to inclusion as healthy volunteer study participant.
• • PART B: Adult (18 years and above) scheduled for elective diagnostic or therapeutic procedures under PS with propofol. No known allergy or hypersensitivity to drugs used for PS or to materials (PP or EVA) comprising STAIRWAY. Medical comorbidity corresponding to ASA class I-III. No cognitive or psychosocial distress. Complete or partial dentation. No mobile teeth, mobile reconstructions or orthodontic braces. Ability to communicate in Swedish. Oral and written informed consent to inclusion as study participant.
• EXCLUSION CRITERIA:
• • PARTS A-B: Withdrawal of informed consent. Suspected or manifest unforeseen severe allergic reaction. Inability to obtain enough useful study data for practical or medicotechnical reasons.