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Recruiting
View on ClinicalTrials.gov

Testing Head position for face mask ventilation for obesity

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

Effectiveness of Two Different Body Positions During Facemask Ventilation in Class 3 Obesity Patients: a Randomized Crossover Trial

Condition: ObesitySponsor: Mount Sinai Hospital, CanadaTarget enrollment: 50
  • 2 groups
  • One site, in Toronto
  • Recruiting
Mount Sinai Hospital, Toronto, Ontario

Interventions

  • Other intervention

    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.

  • Other intervention

    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.

Canadian Sites (1)

1 of 1 recruiting

  • Mount Sinai Hospital

    Toronto, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for11 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +BMI \> 40 kg/m2
  • +age \> 18 years
  • +have the ability to comprehend the rationale for the study and provide consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
  • +scheduled for elective surgery under general anesthesia

Exclusion

  • 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
  • pregnancy,
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to prevent a condition from developing.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Head position for face mask ventilation during induction supine.

Registry label: A: Supine

Group B receives Head position for face mask ventilation during induction head elevated.

Registry label: B: Head elevated

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 50 people.

The study is currently expected to finish around December 2026.

The main measurement is taken over: During induction.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Average tidal volume — measured over During induction.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06305273 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Head position for face mask ventilation during induction supineOther

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.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About Head position for face mask ventilation during induction head elevatedOther

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.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: During induction..

The study as a whole is currently expected to finish around 2026-12-01.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 50 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Toronto, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.