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Completed

NCT Number: NCT06304012

Effect of Oral Enteral Nutrition on Severe Traumatic Brain Injury

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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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jiansheng Hos.

Yilan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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&#39;s family members.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Concentration of hemoglobin

    Time frame: day 1 and day 28

    hemoglobin was tested with blood routine test

  2. Concentration of albumin

    Time frame: day 1 and day 28

    albumin was tested with blood routine test

  3. Concentration of prealbumin

    Time frame: day 1 and day 28

    prealbumin was tested with blood routine test

  4. Nutritional status-body mass index

    Time frame: day 1 and day 28

    body mass index was tested with body weight and height. Combination was calculated as: body weight (kg) / height (m)^2.

Secondary outcomes

  1. Complications-Pulmonary Infections

    Time frame: day 1 and day 28

    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.

  2. Complications-Gastroesophageal Reflux

    Time frame: day 1 and day 28

    Gastroesophageal Reflux: Assessing the occurrence of reflux from the stomach into the esophagus, which can cause symptoms like heartburn and regurgitation.

  3. Complications- Gastrointestinal Bleeding

    Time frame: day 1 and day 28

    Observing for any signs of bleeding within the digestive tract, which may manifest as blood in the stool or vomiting of blood.

  4. Complications-Gastric Retention

    Time frame: day 1 and day 28

    Evaluating whether there was delayed emptying of the stomach contents, leading to symptoms such as bloating, nausea, and vomiting.

  5. Complications-Diarrhea

    Time frame: day 1 and day 28

    Monitoring for loose or watery stools, which may indicate gastrointestinal disturbances or medication side effects.

  6. Complications-Constipation

    Time frame: day 1 and day 28

    Assessing the occurrence of infrequent bowel movements or difficulty passing stools.

  7. Decannulation of tracheostomy tube-placement duration

    Time frame: day 1 and day 28

    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.

  8. Level of consciousness

    Time frame: day 1 and day 28

    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.

Sponsors and collaborators

Lead sponsor

Muhammad

Other

Registry information

Official study title

Oral Versus Nasal Enteral Nutrition on Severe Traumatic Brain Injury Patients With Tracheostomy: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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