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

Schulthess Klinik44 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obese

Interventions

Ambu AuraGainDEVICE

Insert and intubation of an Ambu® AuraGain™ laryngeal mask

Intersurgical i-gelDEVICE

Insert and intubation of an Intersurgical i-gel®

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Schulthess Klinik

Zurich, Switzerland

Outcomes

Primary Outcomes

Time of successful intubation

Measurement of a fiberoptic intubation with the laryngeal mask. Start: Insertion of the fiberoptic into the larynxmask until the intubation has been done and after the fiberoptic has been removed.

Time frame: intraoperative

Secondary Outcomes

Number of Insertions (of the laryngeal mask)

Number of insertion attempts will be registered

Time frame: intraoperative

Time of insertion

The time of Insertion of the laryngeal mask will be recorded.

Time frame: intraoperative

Number of insertion attempts

Number of insertions with the stomach tube will be registered

Time frame: intraoperative

Gastric volume

Measurement of the gastric volume

Time frame: intraoperative

Positioning of the gastric probe

Determination of the position of the gastric probe after successful insertion by stethoscope.

Time frame: intraoperative

Successful Ventilation

Detection of a successful Ventilation. There are two options: a tidal volume \> 6mL/kg lean body mass or endtidal pCO2 \< 6.7kPa

Time frame: intraoperative

Oropharyngeal leak pressure of the Ambu®AuraGain ™

The oropharyngeal leak pressure of the AuraGain™ is measured with a measured cuff volume of 60cmH2O

Data from ClinicalTrials.gov

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