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Clinical Trials/NCT06228170
NCT06228170
Withdrawn
Not Applicable

A Randomized Controlled Study to Explore the Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients

Zeng Changhao1 site in 1 countryJanuary 30, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Zeng Changhao
Locations
1
Primary Endpoint
Penetration-Aspiration Scale
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Detailed Description

Dysphagia, or swallowing difficulty, is a common symptom in Traumatic Brain Injury Patients. The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are: Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients. Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Registry
clinicaltrials.gov
Start Date
January 30, 2024
End Date
May 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zeng Changhao
Responsible Party
Sponsor Investigator
Principal Investigator

Zeng Changhao

Research Director

People's Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

  • age ≥ 18 years, meeting the diagnosis of Traumatic Brain Injury;
  • presence of no contraindication for Stellate Ganglion Block;
  • 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.

Outcomes

Primary Outcomes

Penetration-Aspiration Scale

Time Frame: day 1 and day 20

On the day 1 and day 20, Penetration-Aspiration Scale is used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food enter the airway and caused penetration or aspiration during the swallowing process. As the level increases, the severity of dysphagia also increases.

Secondary Outcomes

  • Modified Barthel Index(day 1 and day 20)
  • Swallowing duration(day 1 and day 20)
  • Functional Oral Intake Scale(day 1 and day 20)

Study Sites (1)

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