Clinical trial
A Randomized Controlled Study to Explore the Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy
Name
2022-KY-1333
Description
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.
Trial arms
Trial start
2022-06-01
Estimated PCD
2023-05-13
Trial end
2023-06-15
Status
Terminated
Treatment
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.
Arms:
the control group, the observation group
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.
Arms:
the observation group
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.
Arms:
the control group
Reserpine
Reserpine was administered to patients to nourish their nerves, with frequency based on their condition.
Arms:
the control group, the observation group
Other names:
neurotrophic drugs
Levofloxacin
The levofloxacin was administered to patients as antibiotic treatment, with frequency based on their condition.
Arms:
the control group, the observation group
Other names:
antibiotic
Size
104
Primary endpoint
Concentration of hemoglobin
day 1 and day 28
Concentration of albumin
day 1 and day 28
Concentration of prealbumin
day 1 and day 28
Nutritional status-body mass index
day 1 and day 28
Eligibility criteria
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 patient\'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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This was a prospective multicenter randomized controlled study, including severe Traumatic Brain Injury patients with tracheostomy transferred to the department of rehabilitation medicine in 3 hospitals from intensive care unit in China between June 2022 and June 2023. Patients enrolled were firstly numbered and then randomly divided into the observation group and the control group. In addition to routine treatments, Intermittent Oro-esophageal Tube Feeding or Nasogastric tube feeding, as nutrition support, was given to patients based on their group. The study lasted 4 weeks for each patient.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 104, 'type': 'ACTUAL'}}
Updated at
2024-03-05
1 organization
2 products
1 indication
Organization
Zeng ChanghaoProduct
ReserpineIndication
Traumatic Brain InjuryProduct
Levofloxacin