Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT03110393
Status:
COMPLETED
Last Update Posted:
2018-01-08
First Post:
2017-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ambu®AuraGain™ Versus I-gel® in Obese Patients
Sponsor:
Schulthess Klinik
Organization:
Study Overview
Official Title:
Prospective Randomized Comparison Between a Fiber Optic Intubation Via the Ambu® AuraGain ™ or the i-Gel® Laryngeal Mask Until a Complete Airway Protection in Obese Patients
Status:
COMPLETED
Status Verified Date:
2018-01
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:
The aim of this study is the randomized comparison of two laryngeal mask (Intersurgical i-gel® and Ambu®AuraGain™) in obese patients
Detailed Description:
Since the incidence of a difficult intubation lies between 4.5% -7.5%, the search for alternative airway devices has been forced in the past.
As an option, the laryngeal mask is suitable, which has been used as a universal airway with a high degree of safety in routine anesthesia.
There are numbers of different laryngeal masks available which have the characteristic to insert an endotracheal tube through the ventilation lumen.
The indications for these laryngeal masks can be extended due to continuous improvements in the laryngeal masks, these laryngeal masks can also be used in obese patients. Obese patients generally have a 4-fold increased risk of a difficult airway, and a BMI over 35 is a predictor of a difficult tracheal intubation.
There are no studies comparing the Intersurgical i-gel® Laryngeal Mask and the Ambu®AuraGain ™ Laryngeal Mask in obese patients.
As an option, the laryngeal mask is suitable, which has been used as a universal airway with a high degree of safety in routine anesthesia.
There are numbers of different laryngeal masks available which have the characteristic to insert an endotracheal tube through the ventilation lumen.
The indications for these laryngeal masks can be extended due to continuous improvements in the laryngeal masks, these laryngeal masks can also be used in obese patients. Obese patients generally have a 4-fold increased risk of a difficult airway, and a BMI over 35 is a predictor of a difficult tracheal intubation.
There are no studies comparing the Intersurgical i-gel® Laryngeal Mask and the Ambu®AuraGain ™ Laryngeal Mask in obese patients.
Study Oversight
Has Oversight DMC:
False
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?: