Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia (OFST-SAP)
2026년 6월 17일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
120
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Qiancheng Luo, MD
- 전화번호: +86 13564781737
- 이메일: luoqiancheng19@163.com
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200135
- Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
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연락하다:
- Qiancheng Luo, MD
- 전화번호: +86 13564781737
- 이메일: luoqiancheng19@163.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Stroke-Associated Pneumonia Within 28 Days
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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28-Day All-Cause Mortality
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Qiancheng Luo, MD, Pudong Gongli Hospital, Shanghai University of Medicine & Health Sciences
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2029년 6월 30일
연구 완료 (추정된)
2029년 7월 31일
연구 등록 날짜
최초 제출
2026년 6월 10일
QC 기준을 충족하는 최초 제출
2026년 6월 10일
처음 게시됨 (실제)
2026년 6월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 17일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PW2023A-51-OFST-SAP
- PW2023A-51 (기타 보조금/기금 번호: Shanghai Pudong New Area Health Commission)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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