Fuehner Thomas, Fuge Jan, Jungen Meike, Buck Anna, Suhling Hendrik, Welte Tobias, Gottlieb Jens, Greer Mark
Department of Internal Medicine, Hannover Medical School, Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), Member of the German Center for Lung Research (DZL).
PLoS One. 2016 Mar 15;11(3):e0150905. doi: 10.1371/journal.pone.0150905. eCollection 2016.
Topical airway anesthesia is known to improve tolerance and patient satisfaction during flexible bronchoscopy (FB). Lidocaine is commonly used, delivered as an atomized spray. The current study assesses safety and patient satisfaction for nasal anesthesia of a new atomization device during outpatient bronchoscopy in lung transplant recipients.
Using a prospective, non-blinded, cross-over design, patients enrolled between 01-10-2014 and 24-11-2014 received 2% lidocaine using the standard reusable nasal atomizer (CRNA). Those enrolled between 25-11-2014 and 30-01-2015, received a disposable intranasal mucosal atomization device (DIMAD). After each procedure, the treating physician, their assistant and the patient independently rated side-effects and satisfaction, basing their responses on visual analogue scales (VAS). At their next scheduled bronchoscopy during the study period, patients then received the alternative atomizer. Written consent was obtained prior to the first bronchoscopy, and the study approved by the institutional ethics committee.
Of the 252 patients enrolled between 01-10-2014 and 30-01-2015, 80 (32%) received both atomizers. Physicians reported better efficacy (p = 0.001) and fewer side effects (p< = 0.001) for DIMAD in patients exposed to both procedures. Among patients with one visit, physicians and their assistants reported improved efficacy (p = 0.018, p = 0.002) and fewer side effects (p< = 0.001, p = 0.029) for the disposable atomizer, whereas patients reported no difference in efficacy or side effects (p = 0.72 and p = 0.20). No severe adverse events were noted. The cost of the reusable device was 4.08€ per procedure, compared to 3.70€ for the disposable device.
Topical nasal anesthesia via a disposable intranasal mucosal atomization device (DIMAD) offers comparable safety and patient comfort, compared to conventional reusable nasal atomizers (CRNA) in lung transplant recipients. Procedural costs were reduced by 0.34€ per procedure.
clinicaltrials.gov NCT02237651.
局部气道麻醉已知可提高可弯曲支气管镜检查（FB）期间的耐受性和患者满意度。利多卡因是常用药物，通过雾化喷雾给药。本研究评估了一种新型雾化装置在肺移植受者门诊支气管镜检查期间用于鼻腔麻醉的安全性和患者满意度。
采用前瞻性、非盲法、交叉设计，2014年10月1日至2014年11月24日期间入组的患者使用标准可重复使用鼻腔雾化器（CRNA）接受2%利多卡因。2014年11月25日至2015年1月30日期间入组的患者接受一次性鼻黏膜雾化装置（DIMAD）。每次操作后，主治医生、其助手和患者根据视觉模拟量表（VAS）独立对副作用和满意度进行评分。在研究期间的下一次预定支气管镜检查时，患者接受另一种雾化器。在首次支气管镜检查前获得书面同意，该研究得到机构伦理委员会的批准。
在2014年10月1日至2015年1月30日期间入组的252例患者中，80例（32%）接受了两种雾化器。对于接受两种操作的患者，医生报告DIMAD的疗效更好（p = 0.001）且副作用更少（p <= 0.001）。在仅接受一次检查的患者中，医生及其助手报告一次性雾化器的疗效有所改善（p = 0.018，p = 0.002）且副作用更少（p <= 0.001，p = 0.029），而患者报告疗效或副作用无差异（p = 0.72和p = 0.20）。未观察到严重不良事件。可重复使用装置每次操作的成本为4.08欧元，而一次性装置为3.70欧元。
与传统的可重复使用鼻腔雾化器（CRNA）相比，通过一次性鼻黏膜雾化装置（DIMAD）进行局部鼻腔麻醉在肺移植受者中具有相当的安全性和患者舒适度。每次操作的程序成本降低了0.34欧元。
clinicaltrials.gov NCT02237651。
