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ethical issues
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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 |
|---|---|---|---|
| the observation group | Experimental | 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). |
|
| the control group | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation therapy | Behavioral |
|
| 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, Doctor | Site Coordinator of United Medical Group located in Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zheng da yi fu yuan hospital | Zhengzhou | Henan | 450000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16983222 | Background | Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001. | |
| 29122524 | Background | Maas AIR, Menon DK, Adelson PD, Andelic N, Bell MJ, Belli A, Bragge P, Brazinova A, Buki A, Chesnut RM, Citerio G, Coburn M, Cooper DJ, Crowder AT, Czeiter E, Czosnyka M, Diaz-Arrastia R, Dreier JP, Duhaime AC, Ercole A, van Essen TA, Feigin VL, Gao G, Giacino J, Gonzalez-Lara LE, Gruen RL, Gupta D, Hartings JA, Hill S, Jiang JY, Ketharanathan N, Kompanje EJO, Lanyon L, Laureys S, Lecky F, Levin H, Lingsma HF, Maegele M, Majdan M, Manley G, Marsteller J, Mascia L, McFadyen C, Mondello S, Newcombe V, Palotie A, Parizel PM, Peul W, Piercy J, Polinder S, Puybasset L, Rasmussen TE, Rossaint R, Smielewski P, Soderberg J, Stanworth SJ, Stein MB, von Steinbuchel N, Stewart W, Steyerberg EW, Stocchetti N, Synnot A, Te Ao B, Tenovuo O, Theadom A, Tibboel D, Videtta W, Wang KKW, Williams WH, Wilson L, Yaffe K; InTBIR Participants and Investigators. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. Lancet Neurol. 2017 Dec;16(12):987-1048. doi: 10.1016/S1474-4422(17)30371-X. Epub 2017 Nov 6. No abstract available. |
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Data were not publicly accessed, but can be obtained under a reasonable request from The First Affiliated Hospital of Zhengzhou University
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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.
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| Intermittent Oro-esophageal Tube Feeding | Device | 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. |
|
| 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. |
|
| Reserpine | Drug | Reserpine was administered to patients to nourish their nerves, with frequency based on their condition. |
|
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| Levofloxacin | Drug | The levofloxacin was administered to patients as antibiotic treatment, with frequency based on their condition. |
|
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| Complications-Gastroesophageal Reflux |
Gastroesophageal Reflux: Assessing the occurrence of reflux from the stomach into the esophagus, which can cause symptoms like heartburn and regurgitation. |
| up to 28 days |
| 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. | up to 28 days |
| Complications-Gastric Retention | Evaluating whether there was delayed emptying of the stomach contents, leading to symptoms such as bloating, nausea, and vomiting. | up to 28 days |
| Complications-Diarrhea | Monitoring for loose or watery stools, which may indicate gastrointestinal disturbances or medication side effects. | up to 28 days |
| Complications-Constipation | Assessing the occurrence of infrequent bowel movements or difficulty passing stools. | up to 28 days |
| 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. | up to 28 days |
| Decannulation of tracheostomy tube-Successful removal | 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 | up to 28 days |
| 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 |
| 32761068 | Background | Hawryluk GWJ, Rubiano AM, Totten AM, O'Reilly C, Ullman JS, Bratton SL, Chesnut R, Harris OA, Kissoon N, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Lumba-Brown A, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury: 2020 Update of the Decompressive Craniectomy Recommendations. Neurosurgery. 2020 Sep 1;87(3):427-434. doi: 10.1093/neuros/nyaa278. |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D012110 | Reserpine |
| D064704 | Levofloxacin |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015016 | Yohimbine |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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