A Comparison of the Intubating Laryngeal Mask FASTRACH™ and the Intubating Laryngeal Mask Ambu Aura-i™
- Conditions
- Fibreoptic IntubationAirway ManagementLaryngeal Mask Airway
- Interventions
- Device: Crossover Ambu Aura-i™ / LMA ETT™Device: Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™Device: Crossover FASTRACH™ / Rüsch Super Safety Silk™Device: Crossover FASTRACH™ / LMA ETT™
- Registration Number
- NCT03109678
- Lead Sponsor
- Asklepios Kliniken Hamburg GmbH
- Brief Summary
The intubating laryngeal mask Fastrach™ is considered a gold standard for blind intubation as well as for fibreoptic guided intubation via a laryngeal mask. Recently, a single use version of the mask has been introduced. The Fastrach single use laryngeal mask is beng compared to the new, low-priced single use intubating laryngeal mask Ambu Aura-i™.
- Detailed Description
Eighty patients undergoing general anaesthesia with planned tracheal intubation for elective surgical procedures are enrolled in the study after checking for inclusion and exclusion criteria. Patients are randomised to either LMA group for blind tracheal intubation with either a standard PVC tracheal tube, or a specifically for the LMA Fastrach developed tube, yielding 4 subgroups.
After a standardised anaesthesia induction, blind intubation is performed in each study group. Different time intervals are documented, such as time to first adequate lung ventilation, or f.e. time for laryngeal mask placement. A crossover-design is performed after unsuccessful intubation, using the alternate LMA or the other tracheal tube. LMA placement is visualised by fibreoptic control.
An estimated success rate for blind intubation of 60% in the Aura-i group versus 90% in the Fastrach group yields a sample size of n= 38. To compensate for dropouts, n=40 subjects are enrolled in each group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- patients undergoing planned general anaesthesia
- planned tracheal intubation
- elective surgical procedure
- 15 to 80 years of age
- ASA physical status IV and V
- severe pulmonary comorbidity (COPD GOLD >III, bronchial asthma)
- indication for rapid-sequence induction
- mouth opening (interincisor distance) <3cm
- morbid obesity (BMI >35kg.m-2)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Aura-i / LMA ETT Crossover Ambu Aura-i™ / LMA ETT™ Blind tracheal intubation: Combination of laryngeal mask Ambu Aura-i™ with LMA ETT™ tracheal tube Aura-i / Rüsch Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™ Blind tracheal intubation: Combination of laryngeal mask Ambu Aura-i™ with Rüsch Super Safety Silk™ tracheal tube Fastrach / Rüsch Crossover FASTRACH™ / Rüsch Super Safety Silk™ Blind tracheal intubation: Combination of laryngeal mask Fastrach™ with Rüsch Super Safety Silk™ tracheal tube Fastrach / LMA ETT Crossover FASTRACH™ / LMA ETT™ Blind tracheal intubation: Combination of laryngeal mask Fastrach™ with LMA ETT™ tracheal tube
- Primary Outcome Measures
Name Time Method success rate of blind intubation through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds overall success rate of blind tracheal intubation within two attempts using either the FASTRACH™ laryngeal mask or the Ambu Aura-i™ laryngeal mask
- Secondary Outcome Measures
Name Time Method subjective handling score through study completion; the handling of the laryngeal masks during the first placement attempt within 60 seconds; directly after placing laryngeal masks and before fibreoptic visualisation, the subjective handling score is documented as above subjective handling score for the two compared laryngeal masks, rated as excellent (1) - poor (4)
influence of tracheal tubes through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds influence of success rates of blind tracheal intubation using different tracheal tubes (Rüsch or LMA-ETT)
equivalence of the laryngeal masks regarding fibreoptic visualisation through study completion; after placing the laryngeal mask and checking for airway leak pressure, fibreoptic visualisation is performed within 60 seconds fibreoptic control of laryngeal mask placement (Fastrach and Aura-i); the position of the larynx relative to the laryngeal cuff and mask-aperture is visualised and categorised as "correct", "lateral deviation", "epiglottic downfolding" or "not assessable"; additionally, the view on the larynx comparable to Cormack/Lehane score is recorded
differences in airway leak pressure through study completion; right after placing the laryngeal mask and checking for correct positioning, ALP is documented within 60 seconds differences in airway leak pressure (ALP) of the two compared laryngeal masks, in cm H2O; presence of audible leakage as well as the absence of corresponding pressure increase on the monitor recorded by setting the APL valve to 40cm H2O, and fresh gas flow at 3l/min
incidence of postoperative sore throat and hoarseness patient interview 24 hours post procedural incidence of postoperative sore throat and hoarseness as well as difficulty swallowing as reported by the study patients ("none", "moderate", "severe")