Clinical trial NCT03110393: Ambu®AuraGain™ Versus I-gel® in Obese Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Keywords: Obese
Laryngeal Mask Airway
Anaesthesia
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time of successful intubation
timeFrame: intraoperative
Secondary outcomes:
measure: Number of Insertions (of the laryngeal mask)
timeFrame: intraoperative
measure: Time of insertion
timeFrame: intraoperative
measure: Number of insertion attempts
timeFrame: intraoperative
measure: Gastric volume
timeFrame: intraoperative
measure: Positioning of the gastric probe
timeFrame: intraoperative
measure: Successful Ventilation
timeFrame: intraoperative
measure: Oropharyngeal leak pressure of the Ambu®AuraGain ™
timeFrame: intraoperative
measure: Oropharyngeal leak pressure of the Intersurgical i-gel®
timeFrame: intraoperative
measure: Measurement of blood pressure
timeFrame: intraoperative
measure: Measurement of oxygen saturation
timeFrame: intraoperative
measure: Measurement of heart rate
timeFrame: intraoperative
measure: Maximum ventilation pressure
timeFrame: intraoperative
measure: Measurement CO2 (kPa):
timeFrame: intraoperative
measure: Number of intubation attempts
timeFrame: intraoperative
measure: Reasons for the unsuccessful intubation
timeFrame: intraoperative
measure: Number of esophageal intubations
timeFrame: intraoperative
measure: Resistance (for an EET):
timeFrame: intraoperative
measure: Location of the mask (Brimacombe)
timeFrame: intraoperative
measure: Swallowing (no / little / medium / strong)
timeFrame: 5hour postoperative
measure: Throat pain (no / little / medium / strong)
timeFrame: 5hour postoperative
measure: Hoarseness (no / little / medium / strong)
timeFrame: 5hour postoperative
measure: Blood on laryngeal mask after intubation
timeFrame: intraoperative
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik
name: Berthold Berthold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moser B, Keller C, Audige L, Dave MH, Bruppacher HR. Fiberoptic intubation of severely obese patients through supraglottic airway: A prospective, randomized trial of the Ambu(R) AuraGain laryngeal mask vs the i-gel airway. Acta Anaesthesiol Scand. 2019 Feb;63(2):187-194. doi: 10.1111/aas.13242. Epub 2018 Aug 8.