Head-elevated mask ventilation in severely obese patients
Official title: Effectiveness of Two Different Body Positions During Facemask Ventilation in Class 3 Obesity Patients: a Randomized Crossover Trial
Run by Mount Sinai Hospital, Canada · NCT06305273 · Data updated 2026-11-12
In adults with BMI of 40 or more undergoing surgery, this study tests whether a head-elevated position improves oxygen delivery when using a face mask during anesthesia compared with lying flat.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | March 25, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | June 17, 2026 |
| Trial ID | NCT06305273 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with BMI ≥ 40 kg/m² scheduled for elective surgery under general anesthesia.
✕Probably not a fit
Patients with BMI ≥ 40 kg/m² who do not respond to positional changes or have contraindications to alternative positions may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares two body positions during facemask ventilation after induction of general anesthesia in adults with class III obesity. Participants will be randomized to be ventilated in a supine position or in a head-elevated position, then switched to the other position to compare ventilation parameters in both setups. The primary goal is to see if head elevation improves lung ventilation measurements and oxygenation in severely obese patients. The trial is conducted at Mount Sinai Hospital in Toronto and does not involve a drug intervention. Outcomes focus on airway performance and safety during mask ventilation.
Why it matters
Potential benefit: If successful, the head-elevated position could provide a simple maneuver to improve ventilation in severely obese patients during anesthesia.
How similar studies have gone: Previous research suggests head-elevated positioning can improve mask ventilation in obese patients, but data in BMI ≥ 40 kg/m² is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI \> 40 kg/m2 * age \> 18 years * scheduled for elective surgery under general anesthesia * have the ability to comprehend the rationale for the study and provide consent Exclusion Criteria: * pregnancy, * risk of aspiration of gastric content * patients using glucagon-like peptide(GLP)-1 agonists * emergency cases * upper airway disease or airway anatomical abnormalities * presence of major cardiovascular, respiratory, or cerebral vascular disease * if the provider anesthesiologist indicates an awake technique to secure the airway
Where it's running
-
Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Fabricio Zasso, MD — Mount Sinai Hospital
- Study coordinator: Fabricio Zasso, MD
- Email: Fabricio.Zasso@sinaihealth.ca
- Phone: 416-586-4800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.