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

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

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

Study Overview

• Status: Completed
• Conditions: Obese
• Intervention / Treatment: Device: Ambu AuraGain; Device: Intersurgical i-gel

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • Schulthess Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ambu® AuraGain™; Intervention with Ambu® AuraGain™Laryngeal Mask	Device: Ambu AuraGain; Insert and intubation of an Ambu® AuraGain™ laryngeal mask
Active Comparator: Intersurgical i-gel®; Intervention with Intersurgical i-gel® Laryngeal Mask	Device: Intersurgical i-gel; Insert and intubation of an Intersurgical i-gel®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Insertions (of the laryngeal mask)	Number of insertion attempts will be registered	intraoperative
Time of insertion	The time of Insertion of the laryngeal mask will be recorded.	intraoperative
Number of insertion attempts	Number of insertions with the stomach tube will be registered	intraoperative
Gastric volume	Measurement of the gastric volume	intraoperative
Positioning of the gastric probe	Determination of the position of the gastric probe after successful insertion by stethoscope.	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	intraoperative
Oropharyngeal leak pressure of the Ambu®AuraGain ™	The oropharyngeal leak pressure of the AuraGain™ is measured with a measured cuff volume of 60cmH2O	intraoperative
Oropharyngeal leak pressure of the Intersurgical i-gel®	The oropharyngeal leak pressure of the Intersurgical i-gel® is measured.	intraoperative
Measurement of blood pressure	Measurement of blood pressure during 5min (1 measurement / minute).	intraoperative
Measurement of oxygen saturation	Measurement oxygen saturation during 5min (1 measurement / minute).	intraoperative
Measurement of heart rate	Measurement of heart rate during 5min (1 measurement / minute).	intraoperative
Maximum ventilation pressure	The maximum ventilation pressure is measured, which must be applied in order to adequately ventilate the patients. This is measured over 5 minutes	intraoperative
Measurement CO2 (kPa):	The exhaled CO2 is determined continuously.	intraoperative
Number of intubation attempts	The number of intubation attempts until successful intubation is recorded.	intraoperative
Reasons for the unsuccessful intubation	The reasons are listed in tabular form.	intraoperative
Number of esophageal intubations	The number of esophageal intubations is measured.	intraoperative
Resistance (for an EET):	The resistance is measured with a score of 1- 4. 1: simple passage, no resistance, 2: little resistance for the passage, 3: significant resistance for the passage, 4: passage not possible	intraoperative
Location of the mask (Brimacombe)	The position of the mask is determined by pushing the fiber optic to a maximum of 1cm over the LMA and then using the Brimacombe score.	intraoperative
Swallowing (no / little / medium / strong)	The swallowing difficulties are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).	5hour postoperative
Throat pain (no / little / medium / strong)	The throat pain is questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).	5hour postoperative
Hoarseness (no / little / medium / strong)	The swallowing difficulties, the throat pain and the hoarseness are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).	5hour postoperative
Blood on laryngeal mask after intubation	Determination of the visible blood on the laryngeal mask after removal (no, little, much).	intraoperative

Collaborators and Investigators

• Sponsor: Schulthess Klinik
• Investigators: Principal Investigator: Berthold Berthold, MD, Schulthess Klinik

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): September 6, 2017
• Study Completion (Actual): September 6, 2017

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Obese; Anaesthesia; Laryngeal Mask Airway
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: Schulthess_Anä_10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No