Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy (STBI)

A Randomized Controlled Study to Explore the Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy

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.

Study Overview

• Status: Terminated
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Rehabilitation therapy; Device: Intermittent Oro-esophageal Tube Feeding; Drug: Reserpine; Drug: Levofloxacin; Device: Nasogastric tube feeding

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Zheng da yi fu yuan hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Behavioral: Rehabilitation therapy; 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.; Device: 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.; Drug: Reserpine; Reserpine was administered to patients to nourish their nerves, with frequency based on their condition.; Other Names: neurotrophic drugs; Drug: Levofloxacin; The levofloxacin was administered to patients as antibiotic treatment, with frequency based on their condition.; Other Names: antibiotic
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	Behavioral: Rehabilitation therapy; 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.; Drug: Reserpine; Reserpine was administered to patients to nourish their nerves, with frequency based on their condition.; Other Names: neurotrophic drugs; Drug: Levofloxacin; The levofloxacin was administered to patients as antibiotic treatment, with frequency based on their condition.; Other Names: antibiotic; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Zeng Changhao
• Investigators: Principal Investigator: Nieto Luis, Doctor, Site Coordinator of United Medical Group located in Miami

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): May 13, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Anti-Infective Agents; Central Nervous System Depressants; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Adrenergic Uptake Inhibitors; Anti-Infective Agents, Urinary; Anti-Bacterial Agents; Levofloxacin; Reserpine
• Other Study ID Numbers: 2022-KY-1333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data were not publicly accessed, but can be obtained under a reasonable request from The First Affiliated Hospital of Zhengzhou University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No