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

NCT ID: NCT06305273

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2025-03-01

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?

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Supine

Participant will be ventilated with facemask while in supine position.

Group Type: EXPERIMENTAL

Head position for face mask ventilation during induction supine

Intervention Type: OTHER

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 elevated

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

Group Type: EXPERIMENTAL

Head position for face mask ventilation during induction head elevated

Intervention Type: OTHER

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.

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabricio Zasso, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Central Contacts

Fabricio Zasso, MD

Role: CONTACT

Fabricio.Zasso@sinaihealth.ca

416-586-4800

Other Identifiers

23-0150-A

Identifier Type: -

Identifier Source: org_study_id