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Completed

NCT Number: NCT03109678

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

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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Key information

Conditions

Airway Management Fibreoptic Intubation Laryngeal Mask Airway

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

Crossover Ambu Aura-i™ / LMA ETT™

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

Crossover FASTRACH™ / Rüsch Super Safety Silk™

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

Crossover FASTRACH™ / LMA ETT™

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

Primary outcomes

  1. success rate of blind intubation

    Time frame: 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 outcomes

  1. influence of tracheal tubes

    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 success rates of blind tracheal intubation using different tracheal tubes (Rüsch or LMA-ETT)

  2. equivalence of the laryngeal masks regarding fibreoptic visualisation

    Time frame: 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

  3. subjective handling score

    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

    subjective handling score for the two compared laryngeal masks, rated as excellent (1) - poor (4)

  4. differences in airway leak pressure

    Time frame: 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

  5. incidence of postoperative sore throat and hoarseness

    Time frame: 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")

Sponsors and collaborators

Lead sponsor

Asklepios Kliniken Hamburg GmbH

Other

Collaborators

  • University of Kiel

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 12, 2017
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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