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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-12

Study Completion Date

2012-03-07

Brief Summary

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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™.

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Detailed Description

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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

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Airway Management Laryngeal Mask Airway Fibreoptic Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Aura-i / Rüsch

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Aura-i / LMA ETT

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

Group Type EXPERIMENTAL

Crossover Ambu Aura-i™ / LMA ETT™

Intervention Type DEVICE

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

Fastrach / Rüsch

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

Group Type EXPERIMENTAL

Crossover FASTRACH™ / Rüsch Super Safety Silk™

Intervention Type DEVICE

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

Fastrach / LMA ETT

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

Group Type EXPERIMENTAL

Crossover FASTRACH™ / LMA ETT™

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No