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Effectiveness of Two Different Body Positions During Facemask Ventilation in Obese Patients

Mount Sinai Hospital, Canada logo

Mount Sinai Hospital, Canada

Status

Not yet enrolling

Conditions

Obesity

Treatments

Other: Head position for face mask ventilation during induction supine
Other: Head position for face mask ventilation during induction head elevated

Study type

Interventional

Funder types

Other

Identifiers

NCT06305273
23-0150-A

Details and patient eligibility

About

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.

Full description

Facemask ventilation is an important technique applied by anesthesiologists after induction of general anesthesia and before tracheal intubation. It is also used as a rescue maneuver in situations where a patient's consciousness is compromised affecting oxygenation. Obesity is well known to be one of the difficult predictors for facemask ventilation. In fact, the occurrence of difficult facemask ventilation is more frequent in obese patients than non obese. One of the maneuvers described to optimize the effectiveness of facemask ventilation in the general population is positioning the patient in a 25 degree head elevated position. A previous study has demonstrated improvement in facemask ventilation in obese patients with BMI from 30 to 40 kg/m2 in the head elevated position, compared to supine. However, it is not yet determined if this is applicable to patients with a BMI above 40 kg/m2. Adult obese patients with BMI of at least 40 kg/m2 will be randomized to be ventilated after induction of general anesthesia via a face mask while in one of the positions: supine or head elevated, while the volume of air that enters and exits the lungs is measured. Participants will then be changed to the second position, ventilated in the same manner and measures obtained again.

Do patients with class 3 obesity positioned in the head elevated position can be better ventilated with a face mask and positive pressure, compared to the supine position?

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

38 participants in 2 patient groups

Supine
Experimental group
Description:
Participant will be ventilated with facemask while in supine position.
Treatment:
Other: Head position for face mask ventilation during induction supine
Head elevated
Experimental group
Description:
Participant will be ventilated with facemask while in head elevated position.
Treatment:
Other: Head position for face mask ventilation during induction head elevated

Trial contacts and locations

0

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Central trial contact

Fabricio Zasso, MD

Data sourced from clinicaltrials.gov

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