Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305273
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-26
Brief Title:
Effectiveness of Two Different Body Positions During Facemask Ventilation in Obese Patients
Sponsor:
Mount Sinai Hospital Canada
Organization:
Mount Sinai Hospital Canada
Study Overview
Official Title:
Effectiveness of Two Different Body Positions During Facemask Ventilation in Class 3 Obesity Patients a Randomized Crossover Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients body using the mask its 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 persons 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
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 patients 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 kgm2 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 kgm2 Adult obese patients with BMI of at least 40 kgm2 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None