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

Obese Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110393
• Other study ID #: Schulthess_Anä_10
• Status: Completed
• Phase: N/A
• First received: March 20, 2017
• Last updated: January 5, 2018
• Start date: April 20, 2017
• Est. completion date: September 6, 2017

Study information

• Verified date: January 2018
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 6, 2017
• Est. primary completion date: September 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obese

Intervention

Device:
• Ambu AuraGain
Insert and intubation of an Ambu® AuraGain™ laryngeal mask
• Intersurgical i-gel
Insert and intubation of an Intersurgical i-gel®

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Insertions (of the laryngeal mask)	Number of insertion attempts will be registered	intraoperative
Secondary	Time of insertion	The time of Insertion of the laryngeal mask will be recorded.	intraoperative
Secondary	Number of insertion attempts	Number of insertions with the stomach tube will be registered	intraoperative
Secondary	Gastric volume	Measurement of the gastric volume	intraoperative
Secondary	Positioning of the gastric probe	Determination of the position of the gastric probe after successful insertion by stethoscope.	intraoperative
Secondary	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
Secondary	Oropharyngeal leak pressure of the Ambu®AuraGain ™	The oropharyngeal leak pressure of the AuraGain™ is measured with a measured cuff volume of 60cmH2O	intraoperative
Secondary	Oropharyngeal leak pressure of the Intersurgical i-gel®	The oropharyngeal leak pressure of the Intersurgical i-gel® is measured.	intraoperative
Secondary	Measurement of blood pressure	Measurement of blood pressure during 5min (1 measurement / minute).	intraoperative
Secondary	Measurement of oxygen saturation	Measurement oxygen saturation during 5min (1 measurement / minute).	intraoperative
Secondary	Measurement of heart rate	Measurement of heart rate during 5min (1 measurement / minute).	intraoperative
Secondary	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
Secondary	Measurement CO2 (kPa):	The exhaled CO2 is determined continuously.	intraoperative
Secondary	Number of intubation attempts	The number of intubation attempts until successful intubation is recorded.	intraoperative
Secondary	Reasons for the unsuccessful intubation	The reasons are listed in tabular form.	intraoperative
Secondary	Number of esophageal intubations	The number of esophageal intubations is measured.	intraoperative
Secondary	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
Secondary	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
Secondary	Swallowing (no / little / medium / strong)	The swallowing difficulties are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).	5hour postoperative
Secondary	Throat pain (no / little / medium / strong)	The throat pain is questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).	5hour postoperative
Secondary	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
Secondary	Blood on laryngeal mask after intubation	Determination of the visible blood on the laryngeal mask after removal (no, little, much).	intraoperative