Clinical trial NCT03109678: A Comparison of the Intubating Laryngeal Mask FASTRACH™ and the Intubating Laryngeal Mask Ambu Aura-i™
Official title: A Comparison of the Intubating Laryngeal Mask FASTRACH™ and the Intubating Laryngeal Mask Ambu Aura-i™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Laryngeal Mask Airway
Fibreoptic Intubation
Lead sponsor: Asklepios Kliniken Hamburg GmbH
Sponsor class: OTHER
Collaborators: name: University of Kiel
First posted: 2017-04-12
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

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™.

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.

Eligibility 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)

Primary outcomes:
measure: success rate of blind intubation
timeFrame: through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds
Secondary outcomes:
measure: influence of tracheal tubes
timeFrame: through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds
measure: equivalence of the laryngeal masks regarding fibreoptic visualisation
timeFrame: through study completion; after placing the laryngeal mask and checking for airway leak pressure, fibreoptic visualisation is performed within 60 seconds
measure: subjective handling score
timeFrame: 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
measure: differences in airway leak pressure
timeFrame: through study completion; right after placing the laryngeal mask and checking for correct positioning, ALP is documented within 60 seconds
measure: incidence of postoperative sore throat and hoarseness
timeFrame: patient interview 24 hours post procedural
Other outcomes:
Locations:
Study officials:
affiliation: Asklepios Kliniken Hamburg GmbH
name: Berthold Bein, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.