Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia (OFST-SAP)
2026年6月17日 更新者：Qiancheng Luo, MD、Shanghai Pudong New Area Gongli Hospital
Translational Application of an Oropharyngeal Flushing Suction Tube Combined With Laryngoscope for Improving Prognosis in Stroke-Associated Pneumonia: A Prospective Randomized Controlled Trial
Stroke-associated pneumonia is a common and clinically important complication after acute ischemic stroke, especially in non-intubated patients with impaired consciousness and reduced cough or swallowing reflexes.
Conventional oral or nasal suction may be insufficient for removing deep oropharyngeal secretions.
This prospective randomized controlled trial will evaluate whether a patented oropharyngeal flushing suction tube combined with direct laryngoscopy reduces the 28-day incidence of stroke-associated pneumonia compared with laryngoscope-guided standard suction and conventional oral/nasal suction.
研究概览
地位
尚未招聘
详细说明
This is an investigator-initiated, single-center, prospective, three-arm, parallel-group, randomized controlled trial.
A total of 120 adult patients with acute ischemic stroke, Glasgow Coma Scale scores of 6 to 12, and no artificial airway or invasive mechanical ventilation at enrollment will be randomized in a 1:1:1 ratio to one of three groups: oropharyngeal flushing suction tube plus laryngoscope, standard suction tube plus laryngoscope, or conventional oral/nasal suction.
All groups will receive standard stroke care and routine oral care.
The primary outcome is the incidence of stroke-associated pneumonia within 28 days after enrollment.
Secondary outcomes include 28-day all-cause mortality, establishment of artificial airway or invasive mechanical ventilation, longitudinal inflammatory biomarkers, pathogen distribution and multidrug-resistant organism detection, and procedure-related adverse events.
研究类型
介入性
注册 (估计的)
120
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。
学习联系方式
- 姓名：Qiancheng Luo, MD
- 电话号码：+86 13564781737
- 邮箱：luoqiancheng19@163.com
学习地点
-
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200135
- Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
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接触：
- Qiancheng Luo, MD
- 电话号码：+86 13564781737
- 邮箱：luoqiancheng19@163.com
-
-
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Confirmed acute ischemic stroke by cranial CT or MRI.
- Age 18 years or older.
- Glasgow Coma Scale score of 6 to 12.
- No artificial airway and no requirement for invasive mechanical ventilation at enrollment.
- Written informed consent provided by the participant or legally authorized representative.
Exclusion Criteria:
- Existing artificial airway or invasive mechanical ventilation at ICU admission or screening.
- Pre-existing pulmonary infection at enrollment, or definite extra-pulmonary organ or tissue infection during the study period.
- Hemorrhagic blood disorder, clinically significant coagulopathy, or bleeding risk precluding laryngoscopy.
- Oral or maxillofacial deformity impeding laryngoscope insertion.
- Cervical spine fracture, atlantoaxial instability, or other condition restricting neck extension or movement.
- Confirmed or suspected pregnancy.
- Irreversible critical illness with anticipated survival less than 28 days.
- Uncontrolled hypertension or recurrent malignant arrhythmias.
- Other conditions judged by investigators to make participation unsuitable.
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Oropharyngeal Flushing Suction Tube Plus Laryngoscope
Participants receive standard stroke care and routine oral care plus direct laryngoscope-guided suction using the oropharyngeal flushing suction tube.
Sterile saline irrigation of approximately 5 mL may be delivered through the irrigation lumen with simultaneous suction when secretions are tenacious.
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A patented single-use dual-lumen suction tube designed for simultaneous irrigation and suction of oropharyngeal and deep pharyngeal secretions under direct laryngoscopic visualization.
The device includes separate irrigation and suction lumens and allows sterile saline irrigation with simultaneous suction when secretions are tenacious.
Direct laryngoscopy is used to visualize the oropharyngeal and glottic area and guide targeted suctioning of oropharyngeal and deep pharyngeal secretions.
|
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有源比较器：Standard Suction Tube Plus Laryngoscope
Participants receive standard stroke care and routine oral care plus direct laryngoscope-guided suction using a standard single-lumen suction catheter.
No oropharyngeal flushing suction tube is used.
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Direct laryngoscopy is used to visualize the oropharyngeal and glottic area and guide targeted suctioning of oropharyngeal and deep pharyngeal secretions.
A conventional single-lumen suction catheter used for oropharyngeal or airway secretion suctioning according to routine clinical practice.
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有源比较器：Conventional Oral or Nasal Suction
Participants receive standard stroke care and routine oral care plus conventional blind oral and/or nasal suction using a standard suction catheter.
No laryngoscope and no flushing suction tube are used.
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Blind oral and/or nasal suctioning performed with a standard suction catheter according to routine clinical practice, without direct laryngoscopic visualization and without use of the oropharyngeal flushing suction tube.
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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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Incidence of Stroke-Associated Pneumonia Within 28 Days
大体时间：Within 28 days after enrollment
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Proportion of participants who meet diagnostic criteria for stroke-associated pneumonia within 28 days after enrollment, adjudicated by blinded outcome assessors using clinical findings, laboratory data, and serial chest imaging.
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Within 28 days after enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
28-Day All-Cause Mortality
大体时间：28 days after enrollment
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Proportion of participants who die from any cause within 28 days after enrollment.
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28 days after enrollment
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Artificial Airway Establishment or Invasive Mechanical Ventilation
大体时间：Within 28 days after enrollment
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Proportion of participants requiring endotracheal intubation, tracheostomy, and/or invasive mechanical ventilation due to respiratory failure or airway protection within 28 days after enrollment.
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Within 28 days after enrollment
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Procedure-Related Adverse Events
大体时间：During each procedure and within 28 days after enrollment
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Occurrence of procedure-related adverse events, including mandibular dislocation, dental injury, mucosal abrasion or laceration, laryngospasm, or intra-procedural oxygen desaturation.
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During each procedure and within 28 days after enrollment
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White Blood Cell Count Over Time
大体时间：Day 0 and Days 3, 7, 10, 14, 18, and 21
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Serial white blood cell count values and changes from baseline.
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Day 0 and Days 3, 7, 10, 14, 18, and 21
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High-Sensitivity C-Reactive Protein Over Time
大体时间：Day 0 and Days 3, 7, 10, 14, 18, and 21
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Serial high-sensitivity C-reactive protein values and changes from baseline.
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Day 0 and Days 3, 7, 10, 14, 18, and 21
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Procalcitonin Over Time
大体时间：Day 0 and Days 3, 7, 10, 14, 18, and 21
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Serial procalcitonin values and changes from baseline.
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Day 0 and Days 3, 7, 10, 14, 18, and 21
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Interleukin-6 Over Time
大体时间：Day 0 and Days 3, 7, 10, 14, 18, and 21
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Serial interleukin-6 values and changes from baseline.
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Day 0 and Days 3, 7, 10, 14, 18, and 21
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Causative Microorganism Distribution
大体时间：On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
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Causative microorganisms identified by quantitative culture and species identification among participants with suspected or confirmed stroke-associated pneumonia.
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On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
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Multidrug-Resistant Organism Detection
大体时间：On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
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Number and proportion of participants with multidrug-resistant organisms identified by antimicrobial susceptibility testing among participants with suspected or confirmed stroke-associated pneumonia.
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On the day of suspected stroke-associated pneumonia and Days 5 and 14 after suspicion
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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：Qiancheng Luo, MD、Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
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 (估计的)
2026年8月1日
初级完成 (估计的)
2029年6月30日
研究完成 (估计的)
2029年7月31日
研究注册日期
首次提交
2026年6月10日
首先提交符合 QC 标准的
2026年6月10日
首次发布 (实际的)
2026年6月15日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PW2023A-51-OFST-SAP
- PW2023A-51 (其他赠款/资助编号：Shanghai Pudong New Area Health Commission)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Identifiable or raw individual participant data will not be publicly shared.
After publication of the primary results, de-identified data may be made available to qualified researchers upon reasonable written request, subject to ethics committee approval and a data-sharing agreement.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.