A comparison of blind intubation with the intubating laryngeal mask FASTRACH™ and the intubating laryngeal mask Ambu Aura-i™ a prospective randomised clinical trial

Abstract

Background: 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. We compared the Fastrach single use with the new, low-priced single use intubating laryngeal mask Ambu Aura-i™. We hypothesised that the LMA Ambu Aura-i and the LMA Fastrach are comparable with respect to success rates for mask placement and blind tracheal intubation through the LMA device.

Methods: A prospective, randomised clinical trial. University Hospital Schleswig-Holstein, Campus Kiel, from April 2011 to April 2012. Eighty patients undergoing general anaesthesia with planned tracheal intubation were randomised and enrolled in the study. Blind intubation was performed with either laryngeal mask using two different tracheal tubes (Rüsch Super Safety Silk™ and LMA ETT™). A crossover-design was performed after an unsuccessful procedure. Primary outcome measure was the overall success rate of blind intubation. Secondary outcome measures were the time to the first adequate ventilation, a subjective handling score, and a fibreoptic control of placement, as well as the success rate of mask placement, time for mask removal after successful intubation, differences in airway leak pressure, and the incidence of postoperative sore throat and hoarseness.

Results: The success rate of tracheal intubation with the Fastrach for the first and second attempt was significantly better compared with the Ambu Aura-i. Tracheal intubation was also significantly faster (14.1 s. ±4.4 versus 21.3 s. ±9.0; p < 0.01), and the time interval for mask removal after successful intubation was significantly shorter using the Fastrach device (24.0 s. ±8.2 versus 29.4 s. ±7.5; p < 0.001). There were no significant differences between groups regarding the incidence of postoperative sore throat and hoarseness.

Conclusion: Both laryngeal mask devices are suitable for ventilation and oxygenation. Blind intubation remains the domain of the LMA Fastrach, the Ambu Aura-i is not suitable for blind intubation.

Trial registration: Clinicaltrials.gov Identification Number NCT03109678 , retrospectively registered on April 12, 2017.

Keywords: Airway management; Fiberoptic intubation; Laryngeal mask airway; Laryngeal mask guided tracheal intubation.

Conflict of interest statement

Ethics approval and consent to participate

Local ethics committee approval - Ethics committee of the Christian-Albrechts-University at Kiel, Chair: Prof. Dr. H.M. Mehdorn, study Ref. No. AZ 107/02, 26.04.2011. Written, informed consent of all patients.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Flow chart study design. 80 patients randomised; two laryngeal mask device groups (Ambu Aura-i™ and Fastrach™) with two subgroups each using two different tracheal tubes (Rüsch Super Safety Silk™ and LMA ETT™)

Fig. 2

Subjective handling score of the two LMA devices. n = number, handling rated as excellent, good, fair, or poor

Fig. 3

Airway leak pressure in both LMA device groups. Box-Whisker-Plot, showing Mean, IQR, Minimum, Maximum, * p < 0.001

Fig. 4

Time for successful intubation on the first attempt in all subgroups, in seconds. Box-Whisker-Plot, showing Mean, IQR, Minimum, Maximum, * p < 0.05, ** p < 0.01