RESPIMER® Netiflow® 与双侧筛窦切除术（鼻息肉病）后鼻腔冲洗期间的生理盐水对比 (NETIFLOW)
2017年8月31日 更新者：Laboratoire de la Mer
一项比较、多中心和随机研究，评估 RESPIMER® Netiflow® 与生理盐水在双侧筛窦切除术后鼻腔冲洗治疗鼻息肉病中的安全性和有效性。
本研究的主要目的是比较 RESPIMER® NetiFlow® 溶液和设备与盐溶液（0.9% NaCl）的效果，标准治疗与 RESPIMER® NetiFlow® 设备一起使用，均用于术后护理，用于筛窦鼻窦手术，术后 14 天。
研究概览
详细说明
这是筛窦手术后两种术后治疗方法的对比研究。 本研究的目的是比较 RESPIMER® NetiFlow® 溶液与标准治疗生理盐水 (0.9% NaCl) 对鼻组织修复的影响。
本研究选择的手术类型是全内窥镜筛窦切除术。 这是一项经常使用的标准手术，平均需要清洁鼻腔 28 天。 这个过程允许伤口的鼻上皮衬里再生（暴露的骨头区域），以及由于手术引起的肿胀和疤痕的愈合。
随访最后 28 天，进行 4 次访问（D7、D14、D21 和 D28）。
RESPIMER® NetiFlow®：I 类设备，带有 CE 标志，用于鼻窦术后护理。
研究类型
介入性
注册 (实际的)
189
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Gironde
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Bordeaux、Gironde、法国、33074
- Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin
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Bordeaux、Gironde、法国、33076
- Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpital Pellegrin
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Haute-Garonne
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Toulouse cedex 9、Haute-Garonne、法国、31059
- ORL et Chirurgie Cervico-faciale - Pôle Voies Respiratoires - CHU Toulouse
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Indre-et-Loire
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Tours cedex 1、Indre-et-Loire、法国、37044
- Service d'ORL et Chirurgie cervico faciale - CHRU Tours
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Loire-Atlantique
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Nantes Cedex 1、Loire-Atlantique、法国、44093
- Service d'oto-rhino-laryngologie - CHU de Nantes
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Meurthe-et-Moselle
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Nancy CEDEX、Meurthe-et-Moselle、法国
- Service ORL et Chirurgie Cervico-faciale - CHRU Nancy
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Nord
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Lille cedex、Nord、法国、59037
- Service ORL et Chirurgie cervico-faciale - CHRU Lille
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Val-de-Marne
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Créteil cedex、Val-de-Marne、法国、94010
- ORL et Chirurgie Cervico-faciale - Centre Hospitalier Intercommunal (CHI) de Créteil
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
14年 至 61年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 18 至 65 岁的男性或女性
需要鼻窦手术的受试者使用内窥镜鼻内入路进行双侧全筛窦切除术，其病理结果是：
- 单纯鼻窦息肉病
- 与哮喘和/或对非甾体抗炎药不耐受相关的鼻窦息肉病
- 自由和知情的书面同意
- 社会保障计划的成员或受益人
排除标准：
- 口服皮质类固醇治疗不到 2 个月
- 未使用有效避孕措施（口服或宫内节育器）的绝经前妇女
- 孕妇或哺乳期妇女
- 不受控制的糖尿病（未经治疗或未通过治疗稳定）
- 艾滋病毒阳性状态
- 影响鼻子和/或鼻窦的自身免疫性疾病、免疫功能障碍（韦格纳肉芽肿病、Churg-Strauss 综合征、常见变异性免疫缺陷病、结节病...）或恶性疾病（组织学不明）
- RESPIMER® NetiFlow® 的所有禁忌症
- 所有导致咳嗽或吞咽困难的疾病
- 头部和颈部正在进行或过去的放射治疗
- 正在进行或最近的化疗（三个月内）
- 使用抗凝剂的受试者
- 参与另一项研究的受试者包括与本研究的导入期一致的排除期
- 受司法保护的对象
- 受试者患有严重的身体或心理问题，并且根据研究者的说法，其状况可能会影响研究的依从性
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：A - 实验性的
治疗组：100 名患者使用 Respimer® NetiFlow® 解决方案作为标准治疗方法治疗内窥镜筛窦切除术后鼻部手术伤口的愈合，作为筛窦手术后的术后护理
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比较两种用于鼻腔清洁的产品，以每天 4 次清洗（每次清洗 240 毫升）的速度作为内窥镜鼻窦手术后的局部术后护理。 这种被称为筛窦切除术的手术旨在改善鼻窦通气、治疗慢性感染区域并切除导致鼻塞的息肉。 有关鼻腔冲洗目的的详细信息，以及如何使用和清洁设备，将在纳入后提供给患者。 洗鼻程序如下：
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有源比较器：B - 比较器
对照组：100 名患者使用生理盐水 (0.9% NaCl) 作为标准疗法治疗内窥镜筛窦切除术后鼻部手术伤口的愈合，作为筛窦手术后的术后护理
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比较两种用于鼻腔清洁的产品，以每天 4 次清洗（每次清洗 240 毫升）的速度作为内窥镜鼻窦手术后的局部术后护理。 这种被称为筛窦切除术的手术旨在改善鼻窦通气、治疗慢性感染区域并切除导致鼻塞的息肉。 有关鼻腔冲洗目的的详细信息，以及如何使用和清洁设备，将在纳入后提供给患者。 洗鼻程序如下：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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内窥镜鼻窦手术后 14 天鼻粘膜修复的卓越愈合，介于 RESPIMER® NetiFlow® 溶液和盐溶液臂之间
大体时间：D14 表示手术后 14 天（正负 3 天）
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基于两组之间 RHINO QoL 总分≥8 分的差异。
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D14 表示手术后 14 天（正负 3 天）
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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优化气道清除和恢复呼吸系统健康以及整体生活质量的功效
大体时间：纳入前、D7、D14、D21 和 D28
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使用以下方法比较 RESPIMER® NetiFlow® 与生理盐水在优化气道清除和恢复呼吸健康以及整体生活质量方面的功效：
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纳入前、D7、D14、D21 和 D28
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评估和比较结痂
大体时间：纳入前、D7、D14、D21 和 D28
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评估和比较结痂：
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纳入前、D7、D14、D21 和 D28
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评估和比较耐受性
大体时间：纳入前、D7、D14、D21 和 D28
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使用视觉模拟量表 (VAS)（鼻子烧灼感、味觉和嗅觉改变以及鼻出血）（患者记录）评估和比较 RESPIMER® NetiFlow® 与生理盐水的耐受性。
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纳入前、D7、D14、D21 和 D28
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有关洗鼻持续时间的其他详细信息
大体时间：术后 D7、D14、D21 和 D28
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根据批准的适应症（患者记录）提供有关洗鼻持续时间的更多详细信息。
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术后 D7、D14、D21 和 D28
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鼻用溶液的满意度和感知功效
大体时间：术后 D7、D14、D21 和 D28
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VAS 数值评估患者对每组使用的鼻腔溶液的满意度和感知功效（患者的病例报告表）。
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术后 D7、D14、D21 和 D28
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RESPIMER® NetiFlow® 设备令人满意、方便、易于管理和易于清洁
大体时间：术后 D7、D14、D21 和 D28
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VAS 数值评估 RESPIMER® NetiFlow® 设备的满意度、便利性、易于管理和易于清洁（患者的病例报告表）。
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术后 D7、D14、D21 和 D28
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评估鼻内衬的功能
大体时间：D-1、D14 和 D21
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通过鼻闪烁显像评估 2 个波尔多中心（波尔多大学医院和圣奥古斯丁私立医院）所有患者的粘膜纤毛清除率来评估鼻内膜的功能：
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D-1、D14 和 D21
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改善手术区域内鼻粘膜营养性的功效
大体时间：D14、D21 和 D28
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使用 Lund-Kennedy 内窥镜评分（20 分）评估 RESPIMER® NetiFlow® 与生理盐水相比在改善手术区域内鼻粘膜营养性方面的功效。
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D14、D21 和 D28
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ludovic LE TAILLANDIER de GABORY, MD, PhD、Coordinator Investigator
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年4月1日
初级完成 (实际的)
2017年2月1日
研究完成 (实际的)
2017年5月1日
研究注册日期
首次提交
2015年9月22日
首先提交符合 QC 标准的
2015年9月22日
首次发布 (估计)
2015年9月24日
研究记录更新
最后更新发布 (实际的)
2017年9月1日
上次提交的符合 QC 标准的更新
2017年8月31日
最后验证
2017年8月1日
更多信息
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