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

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109678
• Other study ID #: AZ 107/02
• Status: Completed
• Phase: N/A
• First received: March 8, 2017
• Last updated: April 11, 2017
• Start date: July 12, 2011
• Est. completion date: March 7, 2012

Study information

• Verified date: April 2017
• Source: Asklepios Kliniken Hamburg GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 7, 2012
• Est. primary completion date: March 7, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Airway Management
• Fibreoptic Intubation
• Laryngeal Mask Airway

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Asklepios Kliniken Hamburg GmbH	University of Kiel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds
Secondary	influence of tracheal tubes	influence of success rates of blind tracheal intubation using different tracheal tubes (Rüsch or LMA-ETT)	through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds
Secondary	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	through study completion; after placing the laryngeal mask and checking for airway leak pressure, fibreoptic visualisation is performed within 60 seconds
Secondary	subjective handling score	subjective handling score for the two compared laryngeal masks, rated as excellent (1) - poor (4)	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
Secondary	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	through study completion; right after placing the laryngeal mask and checking for correct positioning, ALP is documented within 60 seconds
Secondary	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")	patient interview 24 hours post procedural