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

NCT ID: NCT03110393

Last Updated: 2018-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2017-09-06

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.

Conditions

Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ambu® AuraGain™

Intervention with Ambu® AuraGain™Laryngeal Mask

Group Type: EXPERIMENTAL

Ambu AuraGain

Intervention Type: DEVICE

Insert and intubation of an Ambu® AuraGain™ laryngeal mask

Intersurgical i-gel®

Intervention with Intersurgical i-gel® Laryngeal Mask

Group Type: ACTIVE_COMPARATOR

Intersurgical i-gel

Intervention Type: DEVICE

Insert and intubation of an Intersurgical i-gel®

Interventions

Ambu AuraGain

Insert and intubation of an Ambu® AuraGain™ laryngeal mask

Intervention Type: DEVICE

Intersurgical i-gel

Insert and intubation of an Intersurgical i-gel®

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Schulthess Klinik

OTHER

Sponsor Role: lead

Responsible Party

Berthold Moser

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berthold Berthold, MD

Role: PRINCIPAL_INVESTIGATOR

Schulthess Klinik

Locations

Schulthess Klinik

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 30088266 (View on PubMed)

Other Identifiers

Schulthess_Anä_10

Identifier Type: -

Identifier Source: org_study_id