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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03109678
Other study ID # AZ 107/02
Secondary ID
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
Health authority
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)

Study Design


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
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