Effectiveness of Two Different Body Positions During Facemask Ventilation in Obese Patients
ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMount Sinai Hospital, Canada
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
pregnancy,
risk of aspiration of gastric content
patients using glucagon-like peptide(GLP)-1 agonists
emergency cases
Trial design
Design model
Crossover
Treatments tested in this trial
Head position for face mask ventilation during induction supine
Other interventionParticipant 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
Other interventionParticipant 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: SupineExperimental treatment 1 intervention
Group B: Head elevatedExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Average tidal volume
The primary outcome for this trial is the average tidal volume in 10 ventilations in each position, flat or head elevated.
Time frame
During induction.Secondary outcomes
1
Predictors for difficult mask ventilation like BMI
Secondary outcome will be: the incidence and correlation of other predictors for difficult mask ventilation like BMI.
Time frame
During induction2
Predictors for difficult mask ventilation like presence of beard
Secondary outcomes will be: the incidence and correlation of other predictors for difficult mask ventilation like, presence of a beard.
Time frame
During induction3
Predictors for difficult mask ventilation like Mallampati classification III or IV
Secondary outcomes will be: the incidence and correlation of other predictors for difficult mask ventilation like Mallampati classification III or IV.
Time frame
During induction4
Predictors for difficult mask ventilation like age of 57 yo or older.
Secondary outcomes will be: the incidence and correlation of other predictors for difficult mask ventilation like, age of 57 yo or older.
Time frame
During inductionSponsors and contacts
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Source ClinicalTrials.gov