Recruiting

Head Elevation

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT06305273

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Head position for face mask ventilation during induction supine

Head position for face mask ventilation during induction head elevated

Study Details

Brief summary:

It is important to provide enough oxygen to the patients who are asleep during surgery. One way to do this is by using a mask placed over the face to help them breathe. When it becomes difficult getting enough oxygen into the patient's body using the mask, it's called difficult mask ventilation. There can be different reasons for this, and having a higher BMI is one of them. Body physique is assessed by Body Mass Index (BMI). This calculation gives an indication of a person's weight relative to their height.

There is some evidence in the research literature to suggest that when the patient is positioned in a way that helps their airway, like using a device to lift their head and torso 25 degrees , it might help the process of getting enough oxygen work better. The study aims to determine if patients with high BMI can breathe better using a face mask while they are in a head elevated position compared to lying flat on their back.

Conditions

Obesity

Study ID

NCT06305273

Start date

Mar 25, 2024

Status verified date

Jun, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Supine

Participant will be ventilated with facemask while in supine position.

experimental: Head elevated

Participant will be ventilated with facemask while in head elevated position.

Interventions

Head position for face mask ventilation during induction supine

Participant to be ventilated starting 2 minutes after induction of general anesthesia via a face mask while in supine position. Participants will be crossed over to the head elevated position after the first measurement is obtained.

Head position for face mask ventilation during induction head elevated

Participant to be ventilated starting 2 minutes after induction of general anesthesia via a face mask while in head elevated position. Participants will be crossed over to the supine position after the first measurement is obtained.

Primary outcome measure

  • Average tidal volume [ Time Frame: During induction. ]

Central Contacts and Locations

Central contacts

Fabricio Zasso, MD

416-586-4800Fabricio.Zasso@sinaihealth.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Dr. Fabricio B Zasso, MD, MHSc, MBA

416-586-5270Fabricio.Zasso@sinaihealth.ca

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2026-06-17.