Ambu®AuraGain™ Versus I-gel® in Obese Patients

Schulthess Klinik

Status: Completed

Conditions: Obese

Treatments: Device: Ambu AuraGain; Device: Intersurgical i-gel

Study type: Interventional

Funder types: Other

Identifiers

NCT03110393

Schulthess_Anä_10

Details and patient eligibility

About

The aim of this study is the randomized comparison of two laryngeal mask (Intersurgical i-gel® and Ambu®AuraGain™) in obese patients

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA 1-3
• Shoulder-/Elbow-/Hip-/Knee- or Foot - Surgery
• Signed informed consent
• BMI > 35kg/m2

Exclusion criteria

• Non-sober patients (last meal <6 h)
• Symptomatic reflux disease
• Hiatus hernia
• Significant cardiovascular risk factors
• Severe COPD
• Gastric band or gastric bypass
• Disease which allows an accurate examination of the physicians (e.g. neuromuscular, mental, metabolic disease)
• Drug or drug abuse in the recent past
• Legal immaturity (incompetence)
• Acute disease, which calls into question the narcotic potential
• Patients with whom the use of a laryngeal mask is contraindicated or otherwise not possible

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Ambu® AuraGain™

Experimental group

Description:

Intervention with Ambu® AuraGain™Laryngeal Mask

Treatment:

Device: Ambu AuraGain

Intersurgical i-gel®

Active Comparator group

Description:

Intervention with Intersurgical i-gel® Laryngeal Mask

Treatment:

Device: Intersurgical i-gel