Effect of Intermittent Oro-esophageal Tube vs Nasogastric Tube in Tracheostomized Patients With Intracerebral Hemorrhage
- Conditions
- Intracerebral Hemorrhage
- Registration Number
- NCT06203561
- Lead Sponsor
- Zeng Changhao
- Brief Summary
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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- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 118
- 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) .
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of cases of successful extubation 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
- Secondary Outcome Measures
Name Time Method Hemoglobin day 1 and day 30 Hemoglobin was recorded via blood routine test.(Hb, mg/L)
Body mass index day 1 and day 30 Weight and height will be combined to report Body mass index in kg/m\^2
Serum albumin day 1 and day 30 Serum albumin was recorded via blood routine test.(Alb, g/L)
Clinical Pulmonary Infection Score day 1 and day 30 The Clinical Pulmonary Infection Score was recruited for evaluation, with specific assessment indicators such as body temperature, white blood cell count, respiratory secretions, chest X-rays, oxygenation index. The total scores ranged from 0 to 12, with a higher score indicated a more severe pulmonary infection
Trial Locations
- Locations (1)
Zheng da yi fu yuan hospital
🇨🇳Zhengzhou, Henan, China
Zheng da yi fu yuan hospital🇨🇳Zhengzhou, Henan, China