NCT03109678

A Comparison of the Intubating Laryngeal Mask FASTRACH™ and the Intubating Laryngeal Mask Ambu Aura-i™

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Asklepios Kliniken Hamburg GmbH · Academic / Other
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Airway Management
• Laryngeal Mask Airway
• Fibreoptic Intubation

Interventions

Type	Name	Description
DEVICE	Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™	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
DEVICE	Crossover Ambu Aura-i™ / LMA ETT™	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
DEVICE	Crossover FASTRACH™ / Rüsch Super Safety Silk™	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
DEVICE	Crossover FASTRACH™ / LMA ETT™	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

Timeline

• Start date: 2011-07-12
• Primary completion: 2012-03-07
• Completion: 2012-03-07
• First posted: 2017-04-12
• Last updated: 2017-04-12