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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Oro-esophageal Tube Feeding+Rehabilitation therapy | Experimental | Both groups of patients were provided with routine treatments. Based on this, the patients 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). |
|
| Nasogastric tube feeding+Rehabilitation therapy | Active Comparator | Both groups of patients were provided with routine treatments The group was provided nutrition support with Nasogastric tube feeding , while the feeding process strictly followed the relevant guideline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasogastric tube feeding | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of hemoglobin | hemoglobin was tested with blood routine test | day 1 and day 28 |
| Concentration of albumin | albumin was tested with blood routine test | day 1 and day 28 |
| Concentration of prealbumin | prealbumin was tested with blood routine test | day 1 and day 28 |
| Nutritional status-body mass index | body mass index was tested with body weight and height. Combination was calculated as: body weight (kg) / height (m)^2. | day 1 and day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Complications-Pulmonary Infections | During the treatment, the occurrence of complications was recorded for both groups(24). These complications included but were not limited to: 1) Pulmonary Infections: Monitoring for the development of respiratory infections such as pneumonia or bronchitis. | day 1 and day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nieto Luis, Master | Site Coordinator of United Medical Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiansheng Hos. | Yilan | Taiwan |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| Intermittent Oro-esophageal Tube Feeding | Device | 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. |
|
| Rehabilitation therapy | Behavioral | 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. |
|
| Complications-Gastroesophageal Reflux |
Gastroesophageal Reflux: Assessing the occurrence of reflux from the stomach into the esophagus, which can cause symptoms like heartburn and regurgitation. |
| day 1 and day 28 |
| Complications- Gastrointestinal Bleeding | Observing for any signs of bleeding within the digestive tract, which may manifest as blood in the stool or vomiting of blood. | day 1 and day 28 |
| Complications-Gastric Retention | Evaluating whether there was delayed emptying of the stomach contents, leading to symptoms such as bloating, nausea, and vomiting. | day 1 and day 28 |
| Complications-Diarrhea | Monitoring for loose or watery stools, which may indicate gastrointestinal disturbances or medication side effects. | day 1 and day 28 |
| Complications-Constipation | Assessing the occurrence of infrequent bowel movements or difficulty passing stools. | day 1 and day 28 |
| Decannulation of tracheostomy tube-placement duration | The duration of tracheostomy tube retention and the outcomes of decannulation were recorded for two groups during the treatment. The criteria for tracheostomy tube removal were as follows: patients should exhibit no significant pulmonary complications (including the progressive decline in blood oxygen, carbon dioxide retention, pneumonia, etc.) during the capping trial, and should exhibit stable, regular breath and not require reintubation or tracheostomy within 72 hours after tube removal. | day 1 and day 28 |
| Level of consciousness | The Glasgow Coma Scale was used to assess the level of consciousness in patients. A score of 15 indicates normal consciousness, a score of 13-14 indicates mild consciousness impairment, a score of 9-12 indicates moderate consciousness impairment, and a score less than 8 indicates severe consciousness impairment. | day 1 and day 28 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |