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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obese
- Sponsor
- Schulthess Klinik
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Time of successful intubation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Berthold Moser
Principal Investigator
Schulthess Klinik
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Time of successful intubation
Time Frame: 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 Outcomes
- Number of Insertions (of the laryngeal mask)(intraoperative)
- Time of insertion(intraoperative)
- Number of insertion attempts(intraoperative)
- Gastric volume(intraoperative)
- Oropharyngeal leak pressure of the Ambu®AuraGain ™(intraoperative)
- Oropharyngeal leak pressure of the Intersurgical i-gel®(intraoperative)
- Measurement CO2 (kPa):(intraoperative)
- Reasons for the unsuccessful intubation(intraoperative)
- Number of esophageal intubations(intraoperative)
- Resistance (for an EET):(intraoperative)
- Location of the mask (Brimacombe)(intraoperative)
- Swallowing (no / little / medium / strong)(5hour postoperative)
- Positioning of the gastric probe(intraoperative)
- Successful Ventilation(intraoperative)
- Measurement of heart rate(intraoperative)
- Measurement of blood pressure(intraoperative)
- Measurement of oxygen saturation(intraoperative)
- Maximum ventilation pressure(intraoperative)
- Number of intubation attempts(intraoperative)
- Hoarseness (no / little / medium / strong)(5hour postoperative)
- Blood on laryngeal mask after intubation(intraoperative)
- Throat pain (no / little / medium / strong)(5hour postoperative)