Effect of Different Feeding Modes in Intracerebral Hemorrhage: Improving Clinical Outcomes and Safety
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracerebral Hemorrhage
- Sponsor
- Zeng Changhao
- Enrollment
- 118
- Locations
- 2
- Primary Endpoint
- Number of cases of successful extubation
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.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.
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.
Investigators
Zeng Changhao
PI
People's Hospital of Zhengzhou University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •with contraindications for enteral nutrition
- •with dysphagia caused by non-stroke-related reasons in the past
Outcomes
Primary Outcomes
Number of cases of successful extubation
Time Frame: 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 Outcomes
- Body mass index(day 1 and day 30)
- Serum albumin(day 1 and day 30)
- Hemoglobin(day 1 and day 30)
- Clinical Pulmonary Infection Score(day 1 and day 30)
- National Institutes of Health Stroke Scale(day 1 and day 30)