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

Asklepios Kliniken Hamburg GmbH

Status: Completed

Conditions: Fibreoptic Intubation; Laryngeal Mask Airway; Airway Management

Treatments: 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™

Study type: Interventional

Funder types: Other

Identifiers

NCT03109678

AZ 107/02

Details and patient eligibility

About

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™.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing planned general anaesthesia
• planned tracheal intubation
• elective surgical procedure
• 15 to 80 years of age

Exclusion criteria

• 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)

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Aura-i / Rüsch

Experimental group

Description:

Blind tracheal intubation: Combination of laryngeal mask Ambu Aura-i™ with Rüsch Super Safety Silk™ tracheal tube

Treatment:

Device: Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™

Aura-i / LMA ETT

Experimental group

Description:

Blind tracheal intubation: Combination of laryngeal mask Ambu Aura-i™ with LMA ETT™ tracheal tube

Treatment:

Device: Crossover Ambu Aura-i™ / LMA ETT™

Fastrach / Rüsch

Experimental group

Description:

Blind tracheal intubation: Combination of laryngeal mask Fastrach™ with Rüsch Super Safety Silk™ tracheal tube

Treatment:

Device: Crossover FASTRACH™ / Rüsch Super Safety Silk™

Fastrach / LMA ETT

Experimental group

Description:

Blind tracheal intubation: Combination of laryngeal mask Fastrach™ with LMA ETT™ tracheal tube

Treatment:

Device: Crossover FASTRACH™ / LMA ETT™