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

Summary

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.

Conditions

• Traumatic Brain Injury

Interventions

BEHAVIORAL

Rehabilitation therapy

1. Acupuncture: Regular acupuncture treatment that can prevent muscle atrophy, improve circulation, and have a stimulating effect. 2. Exercise therapy: Training that focused on limb movements or joint mobilization to prevent muscle contracture, reduce joint mobility, improve spasms, and promote blood circulation. 3. Others: Regular turning, back patting, and position changes performed by caregivers.

DEVICE

Intermittent Oro-esophageal Tube Feeding

Based on this, the patients in the observation group were given nutrition support with Intermittent Oro-esophageal Tube Feeding (Medical Device No. 20010234, developed by the Swallowing Disorders Research Institute of Zhengzhou University). The entire feeding process strictly followed the standard procedure of Intermittent Oro-esophageal Tube Feeding(18). During the feeding process, patients were maintained in a semi-recumbent position with their head elevated, facilitating the placement of the tube into the oral cavity along one side, with the chin brought close to the manubrium sterni.

DEVICE

Nasogastric tube feeding

The patients in the control group were provided nutrition support with Nasogastric tube feeding, while the feeding process strictly followed the relevant guideline. During the treatment, the patients remained in a continuous state of tube indwelling, receiving feeding every 2-3 hours with a maximum feeding volume of 200ml, of which the contents were consistent with the observation group. The entire feeding process was conducted by trained nursing staff. Besides, the tube was replaced by a new one every 5-7 days.

DRUG

Reserpine

Reserpine was administered to patients to nourish their nerves, with frequency based on their condition.

DRUG

Levofloxacin

The levofloxacin was administered to patients as antibiotic treatment, with frequency based on their condition.

Sponsors & Collaborators

• Zeng Changhao

  lead OTHER

Principal Investigators

• Nieto Luis, Doctor · Site Coordinator of United Medical Group located in Miami

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2023-05-13

Completion

2023-06-15

Countries

• China

Study Locations