A Comparison of the Intubating Laryngeal Mask FASTRACH™ and the Intubating Laryngeal Mask Ambu Aura-i™
1 other identifier
interventional
80
0 countries
N/A
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™.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2011
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2012
CompletedFirst Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedApril 12, 2017
April 1, 2017
8 months
March 8, 2017
April 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
influence of tracheal tubes
through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds
equivalence of the laryngeal masks regarding fibreoptic visualisation
through study completion; after placing the laryngeal mask and checking for airway leak pressure, fibreoptic visualisation is performed within 60 seconds
subjective handling score
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
differences in airway leak pressure
through study completion; right after placing the laryngeal mask and checking for correct positioning, ALP is documented within 60 seconds
incidence of postoperative sore throat and hoarseness
patient interview 24 hours post procedural
Study Arms (4)
Aura-i / Rüsch
EXPERIMENTALBlind tracheal intubation: Combination of laryngeal mask Ambu Aura-i™ with Rüsch Super Safety Silk™ tracheal tube
Aura-i / LMA ETT
EXPERIMENTALBlind tracheal intubation: Combination of laryngeal mask Ambu Aura-i™ with LMA ETT™ tracheal tube
Fastrach / Rüsch
EXPERIMENTALBlind tracheal intubation: Combination of laryngeal mask Fastrach™ with Rüsch Super Safety Silk™ tracheal tube
Fastrach / LMA ETT
EXPERIMENTALBlind tracheal intubation: Combination of laryngeal mask Fastrach™ with LMA ETT™ tracheal tube
Interventions
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
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
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
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
Eligibility Criteria
You may qualify if:
- patients undergoing planned general anaesthesia
- planned tracheal intubation
- elective surgical procedure
- to 80 years of age
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asklepios Kliniken Hamburg GmbHlead
- University of Kielcollaborator
Related Publications (1)
Schiewe R, Stoeck M, Gruenewald M, Hoecker J, Bein B. A comparison of blind intubation with the intubating laryngeal mask FASTRACH and the intubating laryngeal mask Ambu Aura-i a prospective randomised clinical trial. BMC Anesthesiol. 2019 Mar 30;19(1):44. doi: 10.1186/s12871-019-0718-6.
PMID: 30927922DERIVED
Study Officials
- STUDY CHAIR
Berthold Bein, Prof. Dr.
Asklepios Kliniken Hamburg GmbH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
March 8, 2017
First Posted
April 12, 2017
Study Start
July 12, 2011
Primary Completion
March 7, 2012
Study Completion
March 7, 2012
Last Updated
April 12, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share