Comparing feeding methods for patients with severe traumatic brain injury
A Randomized Controlled Study to Explore the Effect of Different Feeding in Traumatic Brain Injury Patients
This study is testing which feeding method works better for patients with severe brain injuries who have a tracheostomy, comparing intermittent tube feeding to nasogastric tube feeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | People's Hospital of Zhengzhou University Academic / other |
| Locations | 1 site (Xinzhu) |
| Trial ID | NCT06249022 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled study investigates the effectiveness of two feeding methods for severe traumatic brain injury patients with tracheostomy. Participants are randomly assigned to receive either Intermittent Oro-esophageal Tube Feeding or Nasogastric tube feeding for nutritional support. The study evaluates various outcomes, including nutritional status, complications, decannulation of tracheostomy tubes, and level of consciousness at baseline and after 28 days. The goal is to determine which feeding method provides better clinical outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with severe traumatic brain injury and a Glasgow Coma Scale score of less than 8.
Not a fit: Patients with severe consciousness disorders caused by other diseases or those unable to cooperate with treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve nutritional support and recovery outcomes for patients with severe traumatic brain injury.
How similar studies have performed: Previous studies have shown varying success with different enteral feeding methods, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury, confirmed through MRI * score of Glasgow Coma Scale (GCS) \<8; * presence of no contraindication for enteral nutrition; * with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications; * informed consent form was obtained from the patients' family members. Exclusion Criteria: * unable to cooperate in completing treatment and assessment due to personal reasons or other disorders; * complicated with other intracranial lesions, such as stroke; * with severe consciousness disorders caused by other diseases.
Where this trial is running
Xinzhu
- Xinzhu Rehabilitation Hospital — Xinzhu, Taiwan (Recruiting)
Study contacts
- Principal investigator: Nieto Luis, Master — Site Coordinator of United Medical Group located in Miami
- Study coordinator: Qianyun Lu, Master
- Email: luqianyun@126.com
- Phone: 19501376864
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.