Clinical trial NCT06248970: The Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy
Official title: A Randomized Controlled Study to Explore Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury;
* score of Glasgow Coma Scale\<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.

Primary outcomes:
measure: Concentration of hemoglobin
timeFrame: day 1 and day 28
measure: Concentration of albumin
timeFrame: day 1 and day 28
measure: Concentration of prealbumin
timeFrame: day 1 and day 28
measure: Nutritional status-body mass index
timeFrame: day 1 and day 28
Secondary outcomes:
measure: Pulmonary Infections
timeFrame: day 1 and day 28
measure: Gastroesophageal Reflux
timeFrame: day 1 and day 28
measure: Gastrointestinal Bleeding
timeFrame: day 1 and day 28
measure: Gastric Retention
timeFrame: day 1 and day 28
measure: Diarrhea
timeFrame: day 1 and day 28
measure: Decannulation of tracheostomy tube-placement duration
timeFrame: day 1 and day 28
measure: Level of consciousness
timeFrame: day 1 and day 28
Other outcomes:
Locations:
city: Zhenzhou
country: China
facility: Zheng Da yi Yuan Hospital
state: Hena
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: STUDY_CHAIR
References: