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Randomized crossover study assessing oropharyngeal leak pressure and fiber optic positioning

Laryngeal Mask Airway Supreme™ versus Laryngeal Tube LTS II™ size 2 in non-paralyzed anesthetized children

Randomized-Crossover-Studie zur Beurteilung von oropharyngealem Verschlussdruck und fiberoptischer Positionierung

Larynxmaske Supreme™ vs. Larynxtubus LTS II™ (Größe 2) bei nichtgelähmten anästhesierten Kindern

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Abstract

Background

As there are currently no data available comparing the practicability of the laryngeal mask airway (LMA) Supreme™ size 2 versus the laryngeal tube LTS II™ size 2 in children, this trial was conducted to quantify the differences between these two airway devices concerning leak pressure and fiber optic-controlled positioning in non-paralyzed, anesthetized pediatric patients.

Methods

A total of 56 children aged 1–6 years and weighing between 11 and 23 kg were enrolled in the study. Anesthesia was intravenously induced according to local standards using fentanyl and propofol. After induction of anesthesia both airway devices were inserted consecutively in accordance with the randomization protocol.

Results

The mean oropharyngeal leak pressure was significantly higher for the LTS II™ (33±8 cmH2O) than for the LMA Supreme™ (21±7 cmH2O, p < 0.0001). Fiber optic position monitoring was better when the LMA Supreme™ was used (p  < 0.001). The first attempt success rates for insertion (55Supreme LMA vs. 43LTSII, p < 0.001), the insertion time (25 s Supreme LMA vs. 34 s LTSII, p < 0.04) and the frequency of bloodstaining (0Supreme LMA vs 4LTSII, p < 0.04) for the initially used device were better for the LMA Supreme™ than the laryngeal tube LTS II™.

Conclusion

We conclude that oropharyngeal leak pressure, fiber optic position, first attempt insertion success rate and bloodstaining differed between the LMA Supreme™ and the LTS II™ in children.

Zusammenfassung

Hintergrund

Ziel der Studie war der Vergleich des Larynxtubus LTS II™ (Größe 2) mit der Larynxmaske Supreme™ (Größe 2) bezüglich oropharyngealem Verschlussdruck und fiberoptischem Lagescore bei Kindern.

Methode

Es wurden 56 Kinder zwischen 18 Monaten und 6 Jahren untersucht. Bei allen Teilnehmern wurde Fentanyl und Propofol zur Anästhesieeinleitung verwendet. Nach Narkoseeinleitung wurden bei allen Teilnehmern nach einer Randomisierungsliste beide Atemwegsdevices getestet (Crossover-Design).

Ergebnisse

Der oropharyngeale Verschlussdruck war höher bei der Verwendung des Larynxtubus LTS II™ (33 [8] cm H2O) höher als bei der Larynxmaske (LMA) Supreme™ (21 [7] cm H2O; p < 0,0001). Der fiberoptische Lagescore war bei Verwendung der LMA SupremeTM deutlich besser (p < 0,0001). Die Erfolgsrate beim ersten Insertionsversuch (55Supreme LMA vs. 43LTS II; p < 0,001), die Insertionszeit (25 s Supreme LMA vs. 34 s LTSII; p < 0,04) und die Inzidenz für Blutauflagerung (0Supreme LMA vs. 4LTSII; p < 0,04) waren höher bei der LMA Supreme™ als beim Larynxtubus LTS II™.

Schlussfolgerung

Beim Einsatz von LMA Supreme™ und Larynxtubus LTS II™ bei Kindern zeigen sich deutliche Unterschiede im oropharyngealen Verschlussdruck, dem fiberoptischen Lagescore, der Insertionserfolgsrate beim ersten Insertionsversuch und der postinterventioneller Blutauflagerung.

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Funding

This project was supported only by departmental resources.

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Correspondence to L. Gasteiger MD.

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Conflict of interest

L. Gasteiger, S. Ofner, B. Stögermüller and B. Ziegler state that there are no conflicts of interest. J. Brimacombe and C. Keller received consultaion fees from Laryngeal Mask Company.

All studies on humans described in this manuscript were carried out with the approval of the responsible ethics committee and in accordance with national law and the Helsinki Declaration of 1975 (in its current revised form). In the case of underage patients, informed consent was obtained from a parent or legal guardian. Ethics committee approval (E-Nr: 1648, approval date on 31.7.2013) was obtained from the Ethikkommission Salzburg, Austria.

Additional information

This report describes human research. IRB contact information: Ethikkommission für das Bundesland Salzburg Sebastian-Stief-Gasse 2, 5020 Salzburg mail: ethikkommission@salzburg.gv.at http://www.salzburg.gv.at/ethikkommission.

This study was conducted with written informed consent from a parent or legal guardian of the study subjects. This report describes a prospective randomized clinical trial. The authors state that the report includes every item in the CONSORT checklist for a prospective randomized clinical trial. This was not an observational clinical study. This manuscript was screened for plagiarism using Plagiarism Checker.

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Gasteiger, L., Ofner, S., Stögermüller, B. et al. Randomized crossover study assessing oropharyngeal leak pressure and fiber optic positioning. Anaesthesist 65, 585–589 (2016). https://doi.org/10.1007/s00101-016-0192-1

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  • DOI: https://doi.org/10.1007/s00101-016-0192-1

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