An interventional study of Ambu AuraGain and Intersurgical i-gel in Obese, sponsored by Schulthess Klinik. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-08.
Sponsored by Schulthess Klinik · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 44 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Schulthess Klinik is the lead sponsor of 52 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention with Ambu® AuraGain™Laryngeal Mask
Device: Ambu AuraGain
Intervention with Intersurgical i-gel® Laryngeal Mask
Device: Intersurgical i-gel
Insert and intubation of an Ambu® AuraGain™ laryngeal mask
Insert and intubation of an Intersurgical i-gel®
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
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
Time frame: intraoperative
Oropharyngeal leak pressure of the Intersurgical i-gel®
The oropharyngeal leak pressure of the Intersurgical i-gel® is measured.
Time frame: intraoperative
Measurement of blood pressure
Measurement of blood pressure during 5min (1 measurement / minute).
Time frame: intraoperative
Measurement of oxygen saturation
Measurement oxygen saturation during 5min (1 measurement / minute).
Time frame: intraoperative
Measurement of heart rate
Measurement of heart rate during 5min (1 measurement / minute).
Time frame: 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
Time frame: intraoperative
Measurement CO2 (kPa):
The exhaled CO2 is determined continuously.
Time frame: intraoperative
Number of intubation attempts
The number of intubation attempts until successful intubation is recorded.
Time frame: intraoperative
Reasons for the unsuccessful intubation
The reasons are listed in tabular form.
Time frame: intraoperative
Number of esophageal intubations
The number of esophageal intubations is measured.
Time frame: 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
Time frame: 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.
Time frame: intraoperative
Swallowing (no / little / medium / strong)
The swallowing difficulties are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).
Time frame: 5hour postoperative
Throat pain (no / little / medium / strong)
The throat pain is questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).
Time frame: 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).
Time frame: 5hour postoperative
Blood on laryngeal mask after intubation
Determination of the visible blood on the laryngeal mask after removal (no, little, much).
Time frame: intraoperative
Plan to share: No
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