Different Feeding in Traumatic Brain Injury Patients

Zeng Changhao

Status: Enrolling

Conditions: Traumatic Brain Injury

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06249022

IOE-TBI xin

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 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.

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 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.

Enrollment: 100 estimated 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 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 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:

Device: Intermittent Oro-esophageal Tube Feeding

Behavioral: Rehabilitation therapy

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