StrokeNCT06211777
Effect of Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on Dysphagia Patients After Stroke
A study testing Intermittent Oro-esophageal Tube Feeding, Nasogastric Tube Feeding and comprehensive rehabilitation therapy in people with Stroke, run by Zeng Changhao at 1 site in China.
Trial summary
This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Intermittent Oro-esophageal Tube Feeding, Nasogastric Tube Feeding and comprehensive rehabilitation therapy
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 1 Apr 2024
- 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
- age ≥ 18 years;
- meeting the diagnostic criteria of stroke;
- any degree of dysphagia at admission;
- steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
- transferred out within three weeks of hospitalization in the neurology department.
Who cannot join
- complicated with other neurological diseases;
- damaged mucosa or incomplete structure in nasopharynx;
- tracheostomy tube plugged;
- unfeasible to the support of parenteral nutrition;
- simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on Dysphagia Patients After Stroke: A Prospective Multicenter Study
This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.
Read the detailed description
Dysphagia in patients after stroke continues to be a challenge. To avoid the wound caused by gastrostomy, nasogastric tube feeding has been the mainstay of palliation, but potential side effects exist this choice. Intermittent Oro-esophageal tube feeding is an established modality that can be used with comprehensive rehabilitation therapy. This study reports the outcomes of Intermittent Oro-esophageal tube feeding and comparison with nasogastric tube feeding, including nutritional status, dysphagia, quality of life, depression, and follow-up in patients receiving comprehensive rehabilitation therapy.This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.
- Conditions
- Stroke
- Being tested
- Intermittent Oro-esophageal Tube Feeding, Nasogastric Tube Feeding, comprehensive rehabilitation therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Oro-esophageal Tube FeedingDevice
The specific procedure was as follows: the infant was placed in a semi-recumbent or sitting position with the head fixed. Before each feeding, the infant's oral and nasal secretions were to be cleared. An intermittent oro-esophageal tube was appropriately lubricated with water on the head part. The professional medical staff held the tube and slowly inserted it through one side of the mouth into the upper part of the esophagus. The depth of insertion depended on the patient's age and height. After each feeding, the tube was immediately removed, and the patient was held upright for at least 30 minutes in case of reflux.
Nasogastric Tube FeedingDevice
Nasogastric Tube Feeding were used for feeding to provide nutritional support. Each feeding was administered by a nurse using the infant's mother's breast milk through the tube. The amount of each feeding varied from 20 to 100 ml depending on the age of the infant, with feedings given every 2 to 3 hours, approximately 10 times per day. The duration of each feeding procedure ranged from 10 to 20 minutes. The total daily intake ranged from 200 to 1000 ml. Each tube was kept indwelling for 5 to 7 days. When the tube needed to be replaced, it was removed after the last feeding of a day and a new tube was to be inserted through the other nostril on the following morning to continue the nutritional support.
comprehensive rehabilitation therapyBehavioural
Both groups were given comprehensive rehabilitation therapy. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.
| Study group | Role | What they receive |
|---|---|---|
| the observation group | Experimental | Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation therapy. The observation group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding. Receives: Device: Intermittent Oro-esophageal Tube Feeding; Behavioral: comprehensive rehabilitation therapy |
| the control group | Active comparator | Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation. The observation group was provided the support of enteral nutrition by Nasogastric Tube Feeding. Receives: Device: Nasogastric Tube Feeding; Behavioral: comprehensive rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration-Aspiration Scale
Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. The scores ranged 1 point to 8 points. As the level increased, the severity of dysphagia also increased.
Measured: day 1 and day 15
Secondary outcomes (6)
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
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 infants 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 infants and in the morning.
Measured: day 1 and day 15
Yale pharyngeal residue severity rating scale
The Yale pharyngeal residue severity rating scale was recruited for assessment, of which the result would be divided into 5 levels (1, no residue; 2, the covered pharyngeal mucosa; 3, mild residue, less than 50%; 4, moderate residue, more than 50%; 5, severe residue, spillage from laryngeal vestibule observed).As the level increased, the severity of dysphagia also increased.
Measured: day 1 and day 15
Patient health questionnaire-9
The depression of the patients was evaluated with the patient health questionnaire-9. The scores ranged 0-27. As the scores increased, the severity of depression also increased.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start10 Jan 2024
- Primary completion10 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Why it stopped: ethical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Master, Principal investigator, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211777
- Sponsor's protocol ID
- 2023-KY-1225
- Status last verified
- Mar 2024
- First submitted
- 7 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on Dysphagia Patients After Stroke: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06211777
- Acronym / sponsor ID
- 2023-KY-1225
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: ethical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 18 Jan 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.
This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.
Detailed description
Dysphagia in patients after stroke continues to be a challenge. To avoid the wound caused by gastrostomy, nasogastric tube feeding has been the mainstay of palliation, but potential side effects exist this choice. Intermittent Oro-esophageal tube feeding is an established modality that can be used with comprehensive rehabilitation therapy. This study reports the outcomes of Intermittent Oro-esophageal tube feeding and comparison with nasogastric tube feeding, including nutritional status, dysphagia, quality of life, depression, and follow-up in patients receiving comprehensive rehabilitation therapy.This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the observation group | Experimental | Device: Intermittent Oro-esophageal Tube Feeding, Behavioral: comprehensive rehabilitation therapyStudy lasts 15 days for each patient. The patients were given comprehensive rehabilitation therapy. The observation group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding. |
| the control group | Active comparator | Device: Nasogastric Tube Feeding, Behavioral: comprehensive rehabilitation therapyStudy lasts 15 days for each patient. The patients were given comprehensive rehabilitation. The observation group was provided the support of enteral nutrition by Nasogastric Tube Feeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years;
- meeting the diagnostic criteria of stroke;
- any degree of dysphagia at admission;
- steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
- transferred out within three weeks of hospitalization in the neurology department.
Key exclusion criteria (5 listed)
- complicated with other neurological diseases;
- damaged mucosa or incomplete structure in nasopharynx;
- tracheostomy tube plugged;
- 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 |
|---|---|---|
| Intermittent Oro-esophageal Tube FeedingThe specific procedure was as follows: the infant was placed in a semi-recumbent or sitting position with the head fixed. Before each feeding, the infant's oral and nasal secretions were to be cleared. An intermittent oro-esophageal tube was appropriately lubricated with water on the head part. The professional medical staff held the tube and slowly inserted it through one side of the mouth into the upper part of the esophagus. The depth of insertion depended on the patient's age and height. After each feeding, the tube was immediately removed, and the patient was held upright for at least 30 minutes in case of reflux. | Device | the observation group |
| Nasogastric Tube FeedingNasogastric Tube Feeding were used for feeding to provide nutritional support. Each feeding was administered by a nurse using the infant's mother's breast milk through the tube. The amount of each feeding varied from 20 to 100 ml depending on the age of the infant, with feedings given every 2 to 3 hours, approximately 10 times per day. The duration of each feeding procedure ranged from 10 to 20 minutes. The total daily intake ranged from 200 to 1000 ml. Each tube was kept indwelling for 5 to 7 days. When the tube needed to be replaced, it was removed after the last feeding of a day and a new tube was to be inserted through the other nostril on the following morning to continue the nutritional support. | Device | the control group |
| comprehensive rehabilitation therapyBoth groups were given comprehensive rehabilitation therapy. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time. | Behavioural | the control group, the observation group |
Primary outcome
Penetration-Aspiration Scale
Time frame: day 1 and day 15
Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. The scores ranged 1 point to 8 points. As the level increased, the severity of dysphagia also increased.
6 secondary outcomes
Body weight
Time frame: day 1 and day 15
Nutritional status-total protein
Time frame: day 1 and day 15
Nutritional status-albumin
Time frame: day 1 and day 15
Yale pharyngeal residue severity rating scale
Time frame: day 1 and day 15
Patient health questionnaire-9
Time frame: day 1 and day 15
Swallowing Quality of Life questionnaire
Time frame: day 1 and day 15
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Nieto Luis, Master principal investigator
Site Coordinator of United Medical Group located in Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Oro-esophageal Tube Feeding, Nasogastric Tube Feeding and comprehensive rehabilitation therapy in people with Stroke, run by Zeng Changhao at 1 site in China.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Penetration-Aspiration Scale (time frame: day 1 and day 15). 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 5 Mar 2024.