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

NCT06199778 | Terminated DMC

• 1 other identifier: 2022-KY-1333
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (9)

• Complications-Pulmonary Infections

  Day 1 and day 28

• Complications-Gastroesophageal Reflux

  up to 28 days

• Complications- Gastrointestinal Bleeding

  up to 28 days

• Complications-Gastric Retention

  up to 28 days

• Complications-Diarrhea

  up to 28 days

Study Arms (2)

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).

Behavioral: Rehabilitation therapy; Device: Intermittent Oro-esophageal Tube Feeding; Drug: Reserpine; Drug: Levofloxacin

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

Behavioral: Rehabilitation therapy; Device: Nasogastric tube feeding; Drug: Reserpine; Drug: Levofloxacin

Interventions

Rehabilitation therapy BEHAVIORAL

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.

the control group; the observation group

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.

the observation group

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.

the control group

Reserpine DRUG

Reserpine was administered to patients to nourish their nerves, with frequency based on their condition.

Also known as: neurotrophic drugs

the control group; the observation group

Levofloxacin DRUG

The levofloxacin was administered to patients as antibiotic treatment, with frequency based on their condition.

Also known as: antibiotic

the control group; the observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\&#39;s family members, indicating their full understanding of the study and agreement to participate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Zheng da yi fu yuan hospital

Zhengzhou, Henan, 450000, China

Location

Related Publications (3)

• 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.

  PMID: 16983222 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.

  PMID: 29122524 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.

  PMID: 32761068 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Rehabilitation; Reserpine; Levofloxacin; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Yohimbine; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Nieto Luis, Doctor

  Site Coordinator of United Medical Group located in Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 10, 2024
• Study Start: June 1, 2022
• Primary Completion: May 13, 2023
• Study Completion: June 15, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)