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

NCT06305273 | Not Yet Recruiting

• 1 other identifier: 23-0150-A
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

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.

  During induction.

Secondary Outcomes (8)

• Predictors for difficult mask ventilation like BMI

  During induction

• Predictors for difficult mask ventilation like presence of beard

  During induction

• Predictors for difficult mask ventilation like Mallampati classification III or IV

  During induction

• Predictors for difficult mask ventilation like age of 57 yo or older.

  During induction

• Predictors for difficult mask ventilation like severely limited mandibular protrusion

  During induction

Study Arms (2)

Supine

EXPERIMENTAL

Participant will be ventilated with facemask while in supine position.

Other: Head position for face mask ventilation during induction supine

Head elevated

EXPERIMENTAL

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

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

Interventions

Head position for face mask ventilation during induction supine 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.

Supine

Head position for face mask ventilation during induction head elevated 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.

Head elevated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabricio Zasso, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabricio Zasso, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective randomized cross-over trial to be conducted at Mount Sinai Hospital (Toronto, Ontario, Canada).

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 12, 2024
• Study Start: March 25, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-02