A Randomized Controlled Study to Explore the Effect of Different Feeding in Traumatic Brain Injury Patients
| Registry | NCT06249022 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 100 (Estimated) |
| Sponsor | Zeng Changhao (Other) |
| Conditions | Traumatic Brain Injury |
| Interventions | Rehabilitation therapy, Intermittent Oro-esophageal Tube Feeding, Nasogastric tube feeding (Behavioral, device) |
| Dates | start 2024-02-20, primary completion 2024-06-01 (estimated), completion 2024-06-01 (estimated), first posted 2024-02-08, last updated 2024-03-07 |
| Locations | 1 site in Taiwan |
Related Papers Related Patents Related Grants Related Experts
All trials for Traumatic Brain Injury All trials of Rehabilitation therapy All trials of Intermittent Oro-esophageal Tube Feeding
This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.
The safe and effective nutrition support for severe traumatic brain injury patients with tracheostomy continues to be a challenge. Nasogastric tube feeding has been the mainstream choice in China but with the risk of complications. Intermittent Oro-esophageal Tube Feeding is an established modality of enteral nutrition support that can be used with routine treatment. This study reports the clinical outcomes of Intermittent Oro-esophageal Tube Feeding vs. nasogastric tube feeding, in patients receiving routine treatment. This was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| The observation group | Experimental | Behavioral: Rehabilitation therapy; Device: Intermittent Oro-esophageal Tube Feeding | Both groups of patients were provided with routine treatments, including pharmacological treatment, rehabilitation therapy.Based on this, the patients in the observation group were given enteral nutrition support with Intermittent Oro-esophageal Tube Feeding (Medical Device No. 20010234, developed by the Swallowing Disorders Research Institute of Zhengzhou University). |
| The control group | Active comparator | Behavioral: Rehabilitation therapy; Device: Nasogastric tube feeding | Both groups of patients were provided with routine treatments, including pharmacological treatment, rehabilitation therapy. The patients in the control group were provided nutrition support with Nasogastric tube feeding , while the feeding process strictly followed the relevant guideline |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Xinzhu Rehabilitation Hospital | Xinzhu | Taiwan | Recruiting |