Efficacy of Naso-Esophageal Tube Feeding in Patients With High Cervical Spinal Cord Injury.

NCT06393205 | Not Yet Recruiting

• 1 other identifier: Bi shidao
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Spinal Cord Injury Cervical

Outcome Measures

Primary Outcomes (4)

• Nutritional status-total protein

  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.

  Day 1 and day 15

• Nutritional status-hemoglobin

  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.

  Day 1 and day 15

• Nutritional status-albumin

  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.

  Day 1 and day 15

• Nutritional status-prealbumin

  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.

  Day 1 and day 15

Secondary Outcomes (4)

• 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

Study Arms (2)

the Naso-Esophageal Tube Feeding group

EXPERIMENTAL

The patients will be given Naso-Esophageal Tube Feeding and routine treatment, for 15 days.

Device: Naso-Esophageal Tube Feeding; Behavioral: Routine treatment

The Nasogastric Tube Feeding group

ACTIVE COMPARATOR

The patients will be given Nasogastric Tube Feeding and routine treatment, for 15 days.

Device: Nasogastric Tube Feeding; Behavioral: Routine treatment

Interventions

Naso-Esophageal Tube Feeding DEVICE

During nasogastric tube feeding, a thin, flexible tube is carefully inserted through one nostril and passed down the throat into the stomach. Once in place, liquid nutrition, medication, or fluids can be administered through the tube, providing essential nutrients and hydration directly to the patient's digestive system. Nasogastric tube feeding may be used temporarily to support patients during acute illness or surgery, or it may be a long-term solution for individuals with chronic conditions that affect their ability to eat normally.

the Naso-Esophageal Tube Feeding group

Nasogastric Tube Feeding DEVICE

The control group was given enteral nutritional support with Nasogastric Tube Feeding according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the patient cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements. The feeding content was formulated by the nutritionists based on the patients condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups. For patients with limited tube feeding compliance, we made appropriate adjustments to ensure that they were not at risk of severe malnutrition as much as possible.

The Nasogastric Tube Feeding group

Routine treatment BEHAVIORAL

Including： Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Pulmonary function training, including standing training, cough training, and diaphragm muscle training.

The Nasogastric Tube Feeding group; the Naso-Esophageal Tube Feeding group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Copka Sonpashan: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04