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

Z

Zeng Changhao

Status

Terminated

Conditions

Traumatic Brain Injury

Treatments

Drug: Levofloxacin
Device: Intermittent Oro-esophageal Tube Feeding
Drug: Reserpine
Device: Nasogastric tube feeding
Behavioral: Rehabilitation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06199778
2022-KY-1333

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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, 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

104 participants in 2 patient groups

the observation group
Experimental group
Description:
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).
Treatment:
Behavioral: Rehabilitation therapy
Drug: Reserpine
Device: Intermittent Oro-esophageal Tube Feeding
Drug: Levofloxacin
the control group
Active Comparator group
Description:
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
Treatment:
Behavioral: Rehabilitation therapy
Device: Nasogastric tube feeding
Drug: Reserpine
Drug: Levofloxacin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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