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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2600126986 |
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最近更新日期: Date of Last Refreshed on: |
2026-06-22 15:37:38 |
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注册时间: Date of Registration: |
2026-06-22 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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注册题目: |
一项评价家用经鼻高流量氧疗在特发性肺纤维化和纤维化型间质性肺疾病患者中的有效性和安全性的24周、随机、对照研究 |
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Public title: |
A 24-Week, Randomized, Controlled Study Evaluating the Efficacy and Safety of Domiciliary High-Flow Nasal Cannula in Patients with Idiopathic Pulmonary Fibrosis and Fibrotic Interstitial Lung Diseases |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
一项评价家用经鼻高流量氧疗在特发性肺纤维化和纤维化型间质性肺疾病患者中的有效性和安全性的24周、随机、对照研究 |
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Scientific title: |
A 24-Week, Randomized, Controlled Study Evaluating the Efficacy and Safety of Domiciliary High-Flow Nasal Cannula in Patients with Idiopathic Pulmonary Fibrosis and Fibrotic Interstitial Lung Diseases |
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研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
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申请注册联系人: |
舒适 |
研究负责人: |
代华平 |
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Applicant: |
Shi Shu |
Study leader: |
Huaping Dai |
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申请注册联系人电话: Applicant telephone: |
+86 13240931333 |
研究负责人电话:
Study leader's |
+86 10 84206408 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
ss_hit@126.com |
研究负责人电子邮件: Study leader's E-mail: |
daihuaping@sina.com |
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申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
北京市朝阳区樱花园东街2号 |
研究负责人通讯地址: |
北京市朝阳区樱花园东街2号 |
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Applicant address: |
No. 2, East Yinghuayuan Street, Chaoyang District, Beijing |
Study leader's address: |
No. 2, East Yinghuayuan Street, Chaoyang District, Beijing |
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申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
中日友好医院 |
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Applicant's institution: |
China-Japan Friendship Hospital |
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研究负责人所在单位: |
中日友好医院 |
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Affiliation of the Leader: |
China-Japan Friendship Hospital |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2024-KY-429-1; 2024-KY-429-3; 2024-KY-429-4 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
中日友好医院临床研究伦理委员会 |
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Name of the ethic committee: |
Clinical Research Ethics Committee of China-Japan Friendship Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-01-02 00:00:00 | ||
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伦理委员会联系人: |
闫旭 |
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Contact Name of the ethic committee: |
Xu Yan |
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伦理委员会联系地址: |
北京市朝阳区樱花园东街2号 |
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Contact Address of the ethic committee: |
No. 2, East Yinghuayuan Street, Chaoyang District, Beijing |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 10 84206250 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
zryyec@126.com |
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研究实施负责(组长)单位: |
中日友好医院 |
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Primary sponsor: |
China-Japan Friendship Hospital |
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研究实施负责(组长)单位地址: |
北京市朝阳区樱花园东街2号 |
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Primary sponsor's address: |
No. 2, East Yinghuayuan Street, Chaoyang District, Beijing |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
Self-funded |
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研究疾病: |
特发性肺纤维化、各种类型间质性肺炎导致的纤维化型间质性肺疾病 |
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Target disease: |
Idiopathic pulmonary fibrosis and fibrotic interstitial lung disease caused by various types of interstitial pneumonia |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
与传统鼻导管吸氧相比,评估家用经鼻高流量氧疗联合鼻导管吸氧在间质性肺炎患者中的有效性及安全性。 |
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Objectives of Study: |
Evaluate the effectiveness and safety of home-based high-flow nasal cannula oxygen therapy combined with conventional nasal cannula oxygen, compared to traditional nasal cannula oxygen alone, in patients with interstitial pneumonia. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
1.诊断为特发性肺纤维化或者纤维化型间质性肺疾病稳定期患者; 2.休息状态,出现中度低氧血症患者(SpO2 89%-93%),或中度运动诱发低氧血症患者(Spo2>=80% >=5 分钟,且 <90% >=10 秒); 3.男性或女性患者>=18 岁; 4.吸烟者,需戒烟3个月以上; 5.如果患者应用激素,剂量<=3片/日持续1个月以上。 |
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Inclusion criteria |
1. Patients diagnosed with idiopathic pulmonary fibrosis or fibrotic interstitial lung disease in a stable phase; 2. Patients with moderate hypoxemia at rest (SpO2 89%-93%) or moderate exercise-induced hypoxemia (SpO2 >=80% for >=5 minutes, and <90% for >=10 seconds); 3. Male or female patients aged 18 or older; 4. Smokers who have quit for more than 3 months; 5. If the patient is on steroids, the dose should be <=3 tablets/day for more than 1 month. |
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排除标准: |
1.经治医生认为患者依从性较差; 2.无法完成肺功能检查或研究相关量表评估(如肺功能很差、脑卒中遗留明显肢体活动障碍、认知障碍等); 3.鼻腔严重堵塞,或无法耐受HFNC; 4.研究者评估基础状态较差,无法参加后续3个月、6个月随访; 5.筛选前1 个月内和/或筛选期间间质性肺炎急性加重; 6.筛选前1个月急性肺栓塞; 7.未控制的传染病,包括活动性肺结核、活动性乙肝、丙肝、HIV 、梅毒; 8.既往或现在有恶性肿瘤的受试者(除外在进入研究筛选前 5 年已达到完全缓解、不需其他治疗方案或预期在研究期间不需要继续治疗的受试者); 9.筛选前 3 个月内发生过心肌梗死、心绞痛、经皮冠状动脉腔内血管成形术、冠状动脉搭桥术、心力衰竭(纽约心脏病协会心功能分级>II 级)、短暂性脑缺血发作、脑梗塞、脑出血或蛛网膜下腔出血; 10.经研究者判断不适合参与本研究。 |
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Exclusion criteria: |
1.Patients deemed by the treating physician to have poor adherence. |
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研究实施时间: Study execute time: |
从 From 2025-06-04 00:00:00至 To 2027-07-01 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-06-04 00:00:00 至 To 2026-12-01 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
由专业统计师通过计算机产生随机数 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
The computer generates random numbers |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
不公开/Private |
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盲法: |
开放标签 |
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Blinding: |
Open-label |
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是否共享原始数据: IPD sharing |
是Yes |
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共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
邮件联系研究者 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Email the researcher |
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数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
EDC |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
EDC |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |