Comparative Study of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients With Intracerebral Hemorrhage: Improving Clinical Outcomes and Safety
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Number of cases of successful extubation
研究概览
简要总结
This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage transferred to the Department of Rehabilitation Medicine of 4 hospitals in China between January 2023 to June 2023.
The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:
Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.
Participants will be divided into two groups randomly, with different nutritional support respectively.
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详细描述
Safe and efficient enteral nutrition support for tracheostomized patients with intracerebral hemorrhage continues to be a challenge. Nasogastric tube feeding has been the mainstay in China but has a significant risk of adverse events. Intermittent oro-esophageal tube feeding is an established enteral nutrition mode that can be used to replace Nasogastric tube feeding. This study reports the clinical effect of Intermittent oro-esophageal tube feeding vs Nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage receiving basic medical treatment and comprehensive rehabilitation therapy.
However, in the field of intracerebral hemorrhage combined with tracheostomy, research on Intermittent oro-esophageal tube feeding is still relatively limited. Therefore, this study was carried out to explore the clinical effect of Intermittent oro-esophageal tube feeding vs. Nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage, mainly on nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit, and intervention-related adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meeting the diagnostic criteria for Intracerebral Hemorrhage.
- •with placement of a tracheotomy tube.
- •requiring enteral nutrition support.
- •age over 18 years.
- •able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) .
排除标准
- •combined with tumors in the head, neck, esophagus, or gastrointestinal tract
- •an abnormal structure observed in the oral, pharyngeal, nasal regions or esophagus
- •with unstable vital signs or severe dysfunction of organs including heart, liver, lungs, or kidneys
- •with severe hemorrhagic disease or bleeding tendency; 5) with contraindications for enteral nutrition
- •with dysphagia caused by non-stroke-related reasons in the past
结局指标
主要结局
Number of cases of successful extubation
时间窗: day 30
The Number of cases of successful extubation for both groups was recorded and compared. The parameters or criteria for extubation were: 1) stable clinical condition and a respiratory rate of 12-22 breaths per minute. 2) strong coughing ability and minimal airway secretions. 3) after completing a trial of tracheostomy tube capping, patients showed no fever, dyspnea, or asthma within 72 hours. Additionally, their blood oxygen saturation remained above 95% and normal oxygen partial pressure was observed
次要结局
- Hemoglobin(day 1 and day 30)
- Body mass index(day 1 and day 30)
- Serum albumin(day 1 and day 30)
- Clinical Pulmonary Infection Score(day 1 and day 30)
研究者
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University