Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy (STBI)

Zeng Changhao

Status: Terminated

Conditions: Traumatic Brain Injury

Treatments: Drug: Levofloxacin; Device: Intermittent Oro-esophageal Tube Feeding; Drug: Reserpine; Device: Nasogastric tube feeding; Behavioral: Rehabilitation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06199778

2022-KY-1333

Details and patient eligibility

About

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 (n=50) or the control group with Nasogastric tube feeding (n=48) 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.

Full description

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 (n=50) or the control group with Nasogastric tube feeding (n=48) 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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 patient&#39;s family members, indicating their full understanding of the study and agreement to participate.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups

the observation group

Experimental group

Description:

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).

Treatment:

Behavioral: Rehabilitation therapy

Drug: Reserpine

Device: Intermittent Oro-esophageal Tube Feeding

Drug: Levofloxacin

the control group

Active Comparator group

Description:

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

Treatment:

Behavioral: Rehabilitation therapy

Device: Nasogastric tube feeding

Drug: Reserpine

Drug: Levofloxacin