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COMPLETED
NCT06328985
NA

Intermittent Oro-esophageal Tube Feeding in Traumatic Brain Injury Patients

Sponsor: Zeng Xi

View on ClinicalTrials.gov

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 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.

Official title: A Randomized Controlled Study to Explore the Effect of Different Feeding in Traumatic Brain Injury Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2024-03-30

Completion Date

2025-10-30

Last Updated

2026-05-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Rehabilitation therapy

Including:Acupuncture: Regular acupuncture treatment that can prevent muscle atrophy, improve circulation, and have a stimulating effect. Exercise therapy: Training that focused on limb movements or joint mobilization to prevent muscle contracture, reduce joint mobility, improve spasms, and promote blood circulation. 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. 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.

Locations (2)

Department of rehabilitation medicine, the first ZU hospital north campus

Zhenzhou, China

Department of rehabilitation medicine, the first ZU hospital western campus

Zhenzhou, China