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.
{"title":"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.","authors":"Vignesh Arumugasamy, Nidhi Agrawal, Anju Gupta","doi":"10.1080/17434440.2026.2695251","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>Mean OSP was higher in Group B at 5 min (29.7 ± 1.4 vs. 24.9 ± 2.1cmH2O; <i>p</i> < 0.0001) and 30 min (29.6 ± 1.3 vs. 24.1 ± 2.6; <i>p</i> < 0.0001). OSP-PAP values were significantly higher in Group B at 5 and 30 min (<i>p</i> < 0.0001). Anatomical alignment was significantly better in Group B (88.6% vs. 57.1%; <i>p</i> = 0.006). The mean times to achieve effective ventilation, ease of device insertion, and gastric catheter insertion were comparable (<i>p</i> = 1.00). Leakage percentages were similar at 5 min (<i>p</i> = 0.11) and 30 min (<i>p</i> = 0.06). .</p><p><strong>Conclusion: </strong>The BlockBuster LMA provided higher OSP, lower PAP-OSP, and better glottic alignment. It may be preferred in children scheduled for elective surgery.</p><p><strong>Clinical trial number and registry url: </strong>CTRI/2024/06/068284 [Registered on: 04/06/2024] Trial Registered Prospectively.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"981-988"},"PeriodicalIF":2.7000,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert review of medical devices","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/17434440.2026.2695251","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/7/1 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
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.
背景:百视达喉罩气道(LMA)提供了一个更高的口咽密封压力(OSP)比Ambu Aura Gain (AAG)在60 cmH2O的儿童。较低的鼻内压可预防咽喉疾病;因此,我们比较了它们在40 cmH2O下的OSP。方法:70例全麻下择期手术患儿随机分为AAG组(A组)和百视达LMA组(B组)。装置放置后,将袖带充气至40 cmH2O压力。记录插入难易程度、OSP、尝试次数、插入时间、声门对准、气道峰值压力(PAP)与OSP之差(ospp -PAP)及漏分。结果:B组5 min时平均OSP增高(29.7±1.4∶24.9±2.1 cmH2O;p p p p = 0.006)。实现有效通气的平均时间、装置插入的难易程度和胃导管插入的难易程度具有可比性(p = 1.00)。渗漏率在5 min (p = 0.11)和30 min (p = 0.06)时相似。结论:与AAG相比,BlockBuster LMA具有更高的OSP,更低的PAP-OSP和更好的声门对准。这可能是首选儿科患者安排择期手术。临床试验编号及注册网址:CTRI/2024/06/068284[注册日期:04/06/2024]前瞻性注册试验。