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™.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
80
After unsuccessful blind intubation in the Ambu Aura-i™ / Rüsch Super Safety Silk™ group: crossover design using the Ambu Aura-i™ mask in combination with the LMA ETT™ tracheal tube
After unsuccessful blind intubation in the Ambu Aura-i™ / LMA ETT group: crossover design using the Ambu Aura-i™ mask in combination with the Rüsch Super Safety Silk™ tracheal tube
After unsuccessful blind intubation in the FASTRACH™ / Rüsch Super Safety Silk™ group: crossover design using the FASTRACH™ mask in combination with the LMA ETT™ tube
success rate of blind intubation
overall success rate of blind tracheal intubation within two attempts using either the FASTRACH™ laryngeal mask or the Ambu Aura-i™ laryngeal mask
Time frame: through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds
influence of tracheal tubes
influence of success rates of blind tracheal intubation using different tracheal tubes (Rüsch or LMA-ETT)
Time frame: through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds
equivalence of the laryngeal masks regarding fibreoptic visualisation
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
Time frame: through study completion; after placing the laryngeal mask and checking for airway leak pressure, fibreoptic visualisation is performed within 60 seconds
subjective handling score
subjective handling score for the two compared laryngeal masks, rated as excellent (1) - poor (4)
Time frame: 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
differences in airway leak pressure
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
After unsuccessful blind intubation in the FASTRACH™ / LMA ETT™ group: crossover design using the FASTRACH™ mask in combination with the Rüsch Super Safety Silk™ tube
Time frame: through study completion; right after placing the laryngeal mask and checking for correct positioning, ALP is documented within 60 seconds
incidence of postoperative sore throat and hoarseness
incidence of postoperative sore throat and hoarseness as well as difficulty swallowing as reported by the study patients ("none", "moderate", "severe")
Time frame: patient interview 24 hours post procedural