Device to keep airways open during sedation
Complementary Systematic Evaluation of a New Medical Device (STAIRWAY) for Open Airways During Sedation
This study is testing a new airway device to see if it works better than standard methods for keeping airways open during sedation in both healthy volunteers and patients having elective procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Stairway Medical AB Industry-sponsored |
| Locations | 1 site (Malmö, Skåne) |
| Trial ID | NCT06270212 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a new airway device called STAIRWAY compared to standard procedures during sedation with propofol. It involves two parts: the first part assesses healthy volunteers to measure airway patency using MRI, while the second part focuses on patients undergoing elective procedures. Participants will be monitored for airway support needs and potential complications like hypoxemia during sedation. The study aims to gather data over a period of six months to determine the device's efficacy.
Who should consider this trial
Good fit: Ideal candidates include adults scheduled for elective procedures requiring sedation with propofol and who meet specific health criteria.
Not a fit: Patients with significant comorbidities or those who cannot communicate in Swedish may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce complications related to airway obstruction during sedation.
How similar studies have performed: While similar studies have explored airway management during sedation, the specific use of the STAIRWAY device represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Malmö, Skåne
- Skåne University Hospital — Malmö, Skåne, Sweden (Recruiting)
Study contacts
- Principal investigator: Jonas Åkeson, Professor — Lund University, Malmö, Sweden
- Study coordinator: Jonas Åkeson, Professor
- Email: jonas.akeson@med.lu.se
- Phone: 0708311113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.