Ambu®AuraGain™ Versus I-gel® in Obese Patients
- Conditions
- Obese
- Registration Number
- NCT03110393
- Lead Sponsor
- Schulthess Klinik
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- ASA 1-3
- Shoulder-/Elbow-/Hip-/Knee- or Foot - Surgery
- Signed informed consent
- BMI > 35kg/m2
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time of successful intubation intraoperative 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.
- Secondary Outcome Measures
Name Time Method Measurement of blood pressure intraoperative Measurement of blood pressure during 5min (1 measurement / minute).
Measurement of oxygen saturation intraoperative Measurement oxygen saturation during 5min (1 measurement / minute).
Number of Insertions (of the laryngeal mask) intraoperative Number of insertion attempts will be registered
Time of insertion intraoperative The time of Insertion of the laryngeal mask will be recorded.
Number of insertion attempts intraoperative Number of insertions with the stomach tube will be registered
Gastric volume intraoperative Measurement of the gastric volume
Oropharyngeal leak pressure of the Ambu®AuraGain ™ intraoperative The oropharyngeal leak pressure of the AuraGain™ is measured with a measured cuff volume of 60cmH2O
Oropharyngeal leak pressure of the Intersurgical i-gel® intraoperative The oropharyngeal leak pressure of the Intersurgical i-gel® is measured.
Measurement CO2 (kPa): intraoperative The exhaled CO2 is determined continuously.
Reasons for the unsuccessful intubation intraoperative The reasons are listed in tabular form.
Number of esophageal intubations intraoperative The number of esophageal intubations is measured.
Resistance (for an EET): intraoperative 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
Location of the mask (Brimacombe) intraoperative 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.
Swallowing (no / little / medium / strong) 5hour postoperative The swallowing difficulties are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).
Positioning of the gastric probe intraoperative Determination of the position of the gastric probe after successful insertion by stethoscope.
Successful Ventilation intraoperative Detection of a successful Ventilation. There are two options: a tidal volume \> 6mL/kg lean body mass or endtidal pCO2 \< 6.7kPa
Measurement of heart rate intraoperative Measurement of heart rate during 5min (1 measurement / minute).
Maximum ventilation pressure intraoperative The maximum ventilation pressure is measured, which must be applied in order to adequately ventilate the patients. This is measured over 5 minutes
Number of intubation attempts intraoperative The number of intubation attempts until successful intubation is recorded.
Hoarseness (no / little / medium / strong) 5hour postoperative The swallowing difficulties, the throat pain and the hoarseness are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).
Blood on laryngeal mask after intubation intraoperative Determination of the visible blood on the laryngeal mask after removal (no, little, much).
Throat pain (no / little / medium / strong) 5hour postoperative The throat pain is questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).
Trial Locations
- Locations (1)
Schulthess Klinik
🇨🇭Zürich, Switzerland
Schulthess Klinik🇨🇭Zürich, Switzerland