Efficacy of Naso-Esophageal Tube Feeding in Patients With High Cervical Spinal Cord Injury.
- Conditions
- Spinal Cord Injury Cervical
- Interventions
- Device: Naso-Esophageal Tube FeedingDevice: Nasogastric Tube FeedingBehavioral: Routine treatment
- Registration Number
- NCT06393205
- Lead Sponsor
- Copka Sonpashan
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- damaged mucosa or incomplete structure in nasopharynx;
- unfeasible to the support of parenteral nutrition;
- simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the Naso-Esophageal Tube Feeding group Naso-Esophageal Tube Feeding The patients will be given Naso-Esophageal Tube Feeding and routine treatment, for 15 days. the Naso-Esophageal Tube Feeding group Routine treatment The patients will be given Naso-Esophageal Tube Feeding and routine treatment, for 15 days. The Nasogastric Tube Feeding group Nasogastric Tube Feeding The patients will be given Nasogastric Tube Feeding and routine treatment, for 15 days. The Nasogastric Tube Feeding group Routine treatment The patients will be given Nasogastric Tube Feeding and routine treatment, for 15 days.
- Primary Outcome Measures
Name Time Method Nutritional status-prealbumin 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 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 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 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 Outcome Measures
Name Time Method Body weight Day 1 and day 15 Body weight measurement of the infants was conducted by the same nurse according to the relevant standards.
Swallowing Quality of Life questionnaire Day 1 and day 15 Swallowing Quality of Life questionnaire was used to evaluate the quality of life, which consists of 44 items and divided into 11 main domains, including: overall satisfaction, understanding, diet, hydration, communication, respiratory issues, postoperative recovery, social impact, mental health, saliva control, and appearance. The maximum rough score was 220 points, which was converted into a standard percentage system in our study. As the scores increased, the quality of life was better.
Dysphagia Handicap Index Day 1 and day 15 Dysphagia Handicap Index is a self-reported questionnaire used to assess the impact of dysphagia on an individual's quality of life. It typically consists of multiple questions related to the physical, functional, and emotional aspects of swallowing difficulties. The total score range varies between 0 and 100. A higher score indicates a greater perceived impact of dysphagia on the individual's quality of life.
Pneumonia Day 1 and day 15 The occurrence of pneumonia in patients was assessed before and after treatment. Specifically, first of all, the symptom assessment and physical examination were conducted to all patients, during which, the doctor would inquire symptoms related to pneumonia, such as cough, sputum production, difficulty breathing, chest pain, etc. and observe the patient's respiratory condition, including respiratory rate, breath sounds, and any abnormal signs in the chest.