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Expert review of medical devices · 2026

Efficacy of two anatomically preformed supraglottic devices, the BlockBuster Laryngeal mask airway and the Ambu AuraGain, for ventilation in anesthetised paralyzed pediatric patients: a randomized trial.

СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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История · было → стало

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Arumugasamy Vignesh, Agrawal Nidhi, Gupta Anju

Аннотация

BACKGROUND: The BlockBuster Laryngeal Mask Airway (LMA) provides a higher oropharyngeal seal pressure (OSP) than Ambu Aura Gain (AAG) in children at an intracuff pressure of 60cmH2O. Lower intracuff pressures prevent laryngopharyngeal morbidity; therefore, we compared their OSP at 40cmH2O.

METHODS: Seventy children scheduled to undergo elective surgery under general anesthesia were randomly assigned to the AAG (Group A) or BlockBuster LMA (Group B) groups. After device placement, the cuff was inflated to 40cmH2O pressure. Ease of insertion, OSP, number of attempts, insertion time, glottic alignment, peak airway pressure (PAP) to OSP difference (OSP-PAP), and leak fraction were recorded.

RESULTS: Mean OSP was higher in Group B at 5 min (29.7 ± 1.4 vs. 24.9 ± 2.1cmH2O; p < 0.0001) and 30 min (29.6 ± 1.3 vs. 24.1 ± 2.6; p < 0.0001). OSP-PAP values were significantly higher in Group B at 5 and 30 min (p < 0.0001). Anatomical alignment was significantly better in Group B (88.6% vs. 57.1%; p = 0.006). The mean times to achieve effective ventilation, ease of device insertion, and gastric catheter insertion were comparable (p = 1.00). Leakage percentages were similar at 5 min (p = 0.11) and 30 min (p = 0.06).            .

CONCLUSION: The BlockBuster LMA provided higher OSP, lower PAP-OSP, and better glottic alignment. It may be preferred in children scheduled for elective surgery.

CLINICAL TRIAL NUMBER AND REGISTRY URL: CTRI/2024/06/068284 [Registered on: 04/06/2024] Trial Registered Prospectively.

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