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临床试验/NCT06508008
NCT06508008招募中不适用

Verification of the Effect of Intermittent Negative Pressure Sputum Suction Through Oral Pharyngeal Ventilation Tube in Comatose Patients

Affiliated Hospital of Nantong University1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2024年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
1
主要终点
Suctioning time

研究概览

简要总结

600 comatose patients admitted to the hospital in China from June 2024 to June 2028 were randomly divided into groups A and B. Group A used intermittent negative pressure suction through oral and pharyngeal ventilation, while group B used continuous negative pressure suction through regular oral and nasal suction.

详细描述

Research content: (1) Selection and placement methods of oropharyngeal ventilation tubes, studying the application effects of different models and sizes of oropharyngeal ventilation tubes in critically ill patients, exploring the best placement method to improve the efficiency and safety of sputum suction operations. (2) The norms and techniques of sputum suction, the steps, techniques, and precautions of sputum suction, the depth, strength, time of insertion, and when to interrupt negative pressure, in order to minimize damage to the patient's respiratory mucosa. (3) Evaluation of patient comfort and tolerance, assessing the tolerance and potential adverse reactions of critically ill patients during oral pharyngeal intubation for sputum suction, providing a basis for optimizing sputum suction. (4) Evaluation of sputum suction effect, comparing blood oxygen saturation, respiratory distress, sputum sounds, and other indicators before and after sputum suction to evaluate the effectiveness of sputum suction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •1. Clinical diagnosis of stroke;
  • •Clinical diagnosis of comatose;

排除标准

  • •1. Clinical diagnosis of multiple organ failure;
  • •Clinical diagnosis of multiple organ bleeding;

研究组 & 干预措施

Intermittent negative pressure sputum suction through oral pharyngeal airway

Experimental

(1) Insert the oropharyngeal airway parallel into the oral cavity; (2) Apply paraffin oil to the front end of the sputum suction tube; (3) The suction tube is inserted into the deep oral cavity through the middle lumen of the oropharyngeal airway; (4) Intermittent negative pressure for suction and suction of sputum

干预措施: Intermittent negative pressure sputum suction through oral pharyngeal airway (Procedure)

continuous negative pressure suction

No Intervention

(1) Use a tongue depressor to open the mouth; (2) Lubricating the front end of the sputum suction tube with paraffin oil; (3) Insert a suction tube into the oral cavity to aspirate phlegm.

Intermittent negative pressure sputum suction through oral pharyngeal airway

Experimental

(1) Insert the oropharyngeal airway parallel into the oral cavity; (2) Apply paraffin oil to the front end of the sputum suction tube; (3) The suction tube is inserted into the deep oral cavity through the middle lumen of the oropharyngeal airway; (4) Intermittent negative pressure for suction and suction of sputum

干预措施: continuous negative pressure suction (Procedure)

结局指标

主要结局

Suctioning time

时间窗: Not exceeding 2 minute

All time required for sputum suction process

Blood oxygen saturation before and after sputum aspiration

时间窗: Not exceeding 1 day

The degree of binding between oxygen and hemoglobin (Hb) in arterial blood

Degree of airway bleeding

时间窗: Not exceeding 30 minute

Use a disposable sputum collection device to aspirate sputum for patients and differentiate the blood content under a blue LED light.

次要结局

  • Patient family satisfaction(Not exceeding 1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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