Clinical trial NCT06305273: Effectiveness of Two Different Body Positions During Facemask Ventilation in Obese Patients
Official title: Effectiveness of Two Different Body Positions During Facemask Ventilation in Class 3 Obesity Patients: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a prospective randomized cross-over trial to be conducted at Mount Sinai Hospital (Toronto, Ontario, Canada).
Primary purpose: PREVENTION

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.

Detailed 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?

Eligibility 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

Primary outcomes:
measure: Average tidal volume
timeFrame: During induction.
Secondary outcomes:
measure: Predictors for difficult mask ventilation like BMI
timeFrame: During induction
measure: Predictors for difficult mask ventilation like presence of beard
timeFrame: During induction
measure: Predictors for difficult mask ventilation like Mallampati classification III or IV
timeFrame: During induction
measure: Predictors for difficult mask ventilation like age of 57 yo or older.
timeFrame: During induction
measure: Predictors for difficult mask ventilation like severely limited mandibular protrusion
timeFrame: During induction
measure: Predictors for difficult mask ventilation like history of snoring.
timeFrame: During induction
measure: Oropharyngeal airway
timeFrame: During induction
measure: Insufficient mask ventilation
timeFrame: During induction.
Other outcomes:
Locations:
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Fabricio Zasso, MD
role: PRINCIPAL_INVESTIGATOR
References: