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Clinical Trials/NCT06393205
NCT06393205
Not yet recruiting
Not Applicable

Efficacy of Naso-Esophageal Tube Feeding in Patients With High Cervical Spinal Cord Injury: A Randomized Controlled Study

Copka Sonpashan0 sites100 target enrollmentApril 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injury Cervical
Sponsor
Copka Sonpashan
Enrollment
100
Primary Endpoint
Nutritional status-prealbumin
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to compare the differences in Pneumonia situation and nutritional status between Patients With High Cervical Spinal Cord Injury using Naso-Esophageal Tube Feeding and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Naso-Esophageal Tube Feeding for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in Pneumonia situation and nutritional status of two groups of patients before and after the study to see if Naso-Esophageal Tube Feeding can improve the Pneumonia situation and nutritional status between Patients With High Cervical Spinal Cord Injury

Detailed Description

Naso-esophageal tube feeding is a medical procedure utilized to provide nutrition directly into the esophagus via a tube inserted through the nose. This method is employed when individuals cannot consume food orally due to various medical conditions, such as dysphagia (difficulty swallowing), neurological disorders, or conditions affecting the upper gastrointestinal tract. The goal of this clinical trial is to compare the differences in Pneumonia situation and nutritional status between Patients With High Cervical Spinal Cord Injury using Naso-Esophageal Tube Feeding and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Naso-Esophageal Tube Feeding for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in Pneumonia situation and nutritional status of two groups of patients before and after the study to see if Naso-Esophageal Tube Feeding can improve the Pneumonia situation and nutritional status between Patients With High Cervical Spinal Cord Injury

Registry
clinicaltrials.gov
Start Date
April 2024
End Date
April 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Copka Sonpashan
Responsible Party
Sponsor Investigator
Principal Investigator

Copka Sonpashan

Research Director

Chao Phya Abhaibhubejhr Hospital

Eligibility Criteria

Inclusion Criteria

  • High Cervical Spinal Cord Injury.
  • any degree of dysphagia at admission;
  • steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.

Exclusion Criteria

  • damaged mucosa or incomplete structure in nasopharynx;
  • unfeasible to the support of parenteral nutrition;
  • simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.

Outcomes

Primary Outcomes

Nutritional status-prealbumin

Time Frame: Day 1 and day 15

The relevant indicators include prealbumin (PA, mg/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach ones and in the morning.

Nutritional status-total protein

Time Frame: Day 1 and day 15

The relevant indicators include total protein (TP, g/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach ones and in the morning.

Nutritional status-albumin

Time Frame: Day 1 and day 15

The relevant indicators include albumin (ALB, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach ones and in the morning.

Nutritional status-hemoglobin

Time Frame: Day 1 and day 15

The relevant indicators include hemoglobin (Hb, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach ones and in the morning.

Secondary Outcomes

  • Body weight(Day 1 and day 15)
  • Swallowing Quality of Life questionnaire(Day 1 and day 15)
  • Dysphagia Handicap Index(Day 1 and day 15)
  • Pneumonia(Day 1 and day 15)

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