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

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ClinicalTrials.gov Identifier: NCT03109678
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
University of Kiel
Information provided by (Responsible Party):
Dr. Robert Schiewe, Asklepios Kliniken Hamburg GmbH

Brief 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™.

Condition or disease Intervention/treatment Phase
Airway Management Laryngeal Mask Airway Fibreoptic Intubation Device: Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™ Device: Crossover Ambu Aura-i™ / LMA ETT™ Device: Crossover FASTRACH™ / Rüsch Super Safety Silk™ Device: Crossover FASTRACH™ / LMA ETT™ Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Comparison of the Intubating Laryngeal Mask FASTRACH™ and the Intubating Laryngeal Mask Ambu Aura-i™
Actual Study Start Date : July 12, 2011
Actual Primary Completion Date : March 7, 2012
Actual Study Completion Date : March 7, 2012

Arm Intervention/treatment
Experimental: Aura-i / Rüsch
Blind tracheal intubation: Combination of laryngeal mask Ambu Aura-i™ with Rüsch Super Safety Silk™ tracheal tube
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

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

Experimental: Fastrach / Rüsch
Blind tracheal intubation: Combination of laryngeal mask Fastrach™ with 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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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")



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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109678


Sponsors and Collaborators
Asklepios Kliniken Hamburg GmbH
University of Kiel
Investigators
Study Chair: Berthold Bein, Prof. Dr. Asklepios Kliniken Hamburg GmbH

Responsible Party: Dr. Robert Schiewe, Doctor, Asklepios Kliniken Hamburg GmbH
ClinicalTrials.gov Identifier: NCT03109678     History of Changes
Other Study ID Numbers: AZ 107/02
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No