Spinal Cord Injury CervicalNCT06393205
Efficacy of Naso-Esophageal Tube Feeding in Patients With High Cervical Spinal Cord Injury.
A study testing Naso-Esophageal Tube Feeding, Nasogastric Tube Feeding and Routine treatment in people with Spinal Cord Injury Cervical, run by Copka Sonpashan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury Cervical
- What is being tested?
- Naso-Esophageal Tube Feeding, Nasogastric Tube Feeding and Routine treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- damaged mucosa or incomplete structure in nasopharynx;
- unfeasible to the support of parenteral nutrition;
- simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
About this study
Official title: Efficacy of Naso-Esophageal Tube Feeding in Patients With High Cervical Spinal Cord Injury: A Randomized Controlled Study
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
Read the 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
- Conditions
- Spinal Cord Injury Cervical
- Being tested
- Naso-Esophageal Tube Feeding, Nasogastric Tube Feeding, Routine treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naso-Esophageal Tube FeedingDevice
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.
Nasogastric Tube FeedingDevice
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.
Routine treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the Naso-Esophageal Tube Feeding group | Experimental | The patients will be given Naso-Esophageal Tube Feeding and routine treatment, for 15 days. Receives: 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. Receives: Device: Nasogastric Tube Feeding; Behavioral: Routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 and day 15
Secondary outcomes (4)
Body weight
Body weight measurement of the infants was conducted by the same nurse according to the relevant standards.
Measured: Day 1 and day 15
Swallowing Quality of Life questionnaire
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.
Measured: Day 1 and day 15
Dysphagia Handicap Index
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.
Measured: Day 1 and day 15
Pneumonia
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.
Measured: Day 1 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copka Sonpashan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Copka Sonpashan, Chao Phya Abhaibhubejhr Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393205
- Sponsor's protocol ID
- Bi shidao
- Status last verified
- Apr 2024
- First submitted
- 27 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Naso-Esophageal Tube Feeding in Patients With High Cervical Spinal Cord Injury: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06393205
- Acronym / sponsor ID
- Bi shidao
- Conditions
- Spinal Cord Injury Cervical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Copka SonpashanOther government
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Naso-Esophageal Tube Feeding group | Experimental | Device: Naso-Esophageal Tube Feeding, Behavioral: Routine treatmentThe patients will be given Naso-Esophageal Tube Feeding and routine treatment, for 15 days. |
| The Nasogastric Tube Feeding group | Active comparator | Device: Nasogastric Tube Feeding, Behavioral: Routine treatmentThe patients will be given Nasogastric Tube Feeding and routine treatment, for 15 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- damaged mucosa or incomplete structure in nasopharynx;
- unfeasible to the support of parenteral nutrition;
- simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naso-Esophageal Tube FeedingDuring 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. | Device | the Naso-Esophageal Tube Feeding group |
| Nasogastric Tube FeedingThe 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. | Device | The Nasogastric Tube Feeding group |
| Routine treatmentIncluding： 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. | Behavioural | The Nasogastric Tube Feeding group, the Naso-Esophageal Tube Feeding group |
Primary outcome
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-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.
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-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.
4 secondary outcomes
Body weight
Time frame: Day 1 and day 15
Swallowing Quality of Life questionnaire
Time frame: Day 1 and day 15
Dysphagia Handicap Index
Time frame: Day 1 and day 15
Pneumonia
Time frame: Day 1 and day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Naso-Esophageal Tube Feeding, Nasogastric Tube Feeding and Routine treatment in people with Spinal Cord Injury Cervical, run by Copka Sonpashan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status-total protein (time frame: Day 1 and day 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.