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

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Xinzhu Rehabilitation Hospital
RECRUITING
Xinzhu
Contact Information
Primary
Qianyun Lu, Master
luqianyun@126.com
19501376864
Backup
Weijia Li, Master
liweijia@163.com
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2024-06
Participants
Target number of participants: 100
Treatments
Experimental: The observation group
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).
Active_comparator: The control group
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
Related Therapeutic Areas
Sponsors
Leads: Zeng Changhao

This content was sourced from clinicaltrials.gov