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

Traumatic Brain Injury Clinical Trial

— STBI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06199778
• Other study ID #: 2022-KY-1333
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 15, 2023

Study information

• Verified date: March 2024
• Source: People's Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: June 15, 2023
• Est. primary completion date: May 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.
• 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.

Drug:
• Reserpine
Reserpine was administered to patients to nourish their nerves, with frequency based on their condition.
• Levofloxacin
The levofloxacin was administered to patients as antibiotic treatment, with frequency based on their condition.

Locations

Country	Name	City	State
China	Zheng da yi fu yuan hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zeng Changhao

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of hemoglobin	hemoglobin was tested with blood routine test	day 1 and day 28
Primary	Concentration of albumin	albumin was tested with blood routine test	day 1 and day 28
Primary	Concentration of prealbumin	prealbumin was tested with blood routine test	day 1 and day 28
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complications-Diarrhea	Monitoring for loose or watery stools, which may indicate gastrointestinal disturbances or medication side effects.	up to 28 days
Secondary	Complications-Constipation	Assessing the occurrence of infrequent bowel movements or difficulty passing stools.	up to 28 days
Secondary	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
Secondary	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
Secondary	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