Comparing feeding methods for patients with brain hemorrhage
Effect of Different Feeding Modes in Intracerebral Hemorrhage: Improving Clinical Outcomes and Safety
This study is testing which feeding method works better for patients with brain hemorrhage who have a tracheostomy, to see if it helps them get better nutrition and recover faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | People's Hospital of Zhengzhou University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06255353 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of two different feeding methods, Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding, in tracheostomized patients suffering from Intracerebral Hemorrhage. The study is multicenter and randomized, aiming to determine which feeding method better improves nutritional status, facilitates extubation of the tracheostomy tube, reduces pulmonary infections, and minimizes neurological deficits. Participants will be randomly assigned to one of the two feeding groups while receiving standard medical treatment and rehabilitation therapy. The trial seeks to address the challenges of enteral nutrition support in this patient population, where traditional methods may pose significant risks.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a diagnosis of Intracerebral Hemorrhage who have a tracheostomy tube and require enteral nutrition support.
Not a fit: Patients with severe organ dysfunction, head or neck tumors, or contraindications for enteral nutrition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective nutritional support methods for patients with Intracerebral Hemorrhage.
How similar studies have performed: While research on Intermittent Oro-esophageal Tube Feeding in this specific context is limited, similar feeding methods have shown promise in other patient populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Center Rehabilitation Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Qianyun Lu, Master
- Email: luqianyun@126.com
- Phone: 15333866454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.