Cerebral Small Vessel DiseasesCSVDNCT06179550

Intermittent Oro-esophageal Tube Feeding on Cerebral Small Vessel Disease Patients With Dysphagia

A study testing Nasogastric tube and Intermittent Oro-esophageal Tube in people with Cerebral Small Vessel Diseases, run by Zeng Changhao at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Cerebral Small Vessel Diseases
What is being tested?: Nasogastric tube and Intermittent Oro-esophageal Tube
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 1 Jan 2023to 22 Jun 2023
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 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of CSVD, confirmed by MRI;
Must be able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) ;
Clinical diagnosis of dysphagia through the Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS);
Age between 40 and 70 years;
Enteral nutrition support was required and feasible.
No history of prior stroke.

Who cannot join

Dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases;
Complicated with severe liver and kidney failure, tumors, or hematological disorders;
Simultaneously need to undergo other therapy that might affect the outcomes of this study;
Unable or unwilling to undergo VFSS;
Pregnant or nursing females.

Trial locations and contacts

1 site in 1 country.

China1 site

Zheng da yi fu yuan hospital
Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Randomized Controlled Study to Explore the Clinical Effect of Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on Cerebral Small Vessel Disease Patients With Dysphagia

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach.

Read the detailed description

This was a randomized controlled study with 60 CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy. Patients enrolled were randomly divided into the observation group (with IOE, n=30) and the control group (with NGT, n=30). At admission and after treatment, Video Fluoroscopic Swallowing Study (VFSS) and Functional Oral Intake Scale (FOIS), body mass index (BMI), serum albumin (Alb), and hemoglobin (Hb), Modified Barthel Index (MBI) and World Health Organization Quality of Life Assessment Instrument Brief Version (WHOQOL-BREF) were recruited to assess and compare dysphagia, nutritional status, activities of daily living (ADL) and quality of life (QOL). The incidence of pneumonia was recorded and compared.

Conditions: Cerebral Small Vessel Diseases
Being tested: Nasogastric tube, Intermittent Oro-esophageal Tube
Keywords: Cerebral Small Vessel Disease, Enteral Nutrition., Intermittent Oro-esophageal Tube Feeding
Medical subject headings: Cerebral Small Vessel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nasogastric tubeDevice
Also called 1) Basic treatment, including corresponding control of risk factors and education on healthy lifestyles., 2) Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training., 3) Pulmonary function training, including standing training, cough training, and diaphragm muscle training.
Besides, the control group was given enteral nutritional support with NGT 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\'s 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 patient\'s 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.
Intermittent Oro-esophageal TubeDevice
Also called 1) Basic treatment, including corresponding control of risk factors and education on healthy lifestyles., 2) Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training., 3) Pulmonary function training, including standing training, cough training, and diaphragm muscle training.
The observation group was given enteral nutritional support with IOE according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm (Appendix). However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.

Study groups in NCT06179550
Study group	Role	What they receive
The control group	Active comparator	Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: 1. Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. 2. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. 3. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. Besides, the control group was given enteral nutritional support with NGT 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\&#39;s 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. Receives: Device: Nasogastric tube
The observation group	Experimental	Assigned by the random number table.During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: 1. Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. 2. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. 3. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. The observation group was given enteral nutritional support with IOE according to the following procedure. The feeding content was formulated by the nutritionists based on the patient\&#39;s 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 Receives: Device: Intermittent Oro-esophageal Tube

What is being measured

The primary outcome is the main question the study is designed to answer.

Video Fluoroscopic Swallowing Study
Video Fluoroscopic Swallowing Study, which is considered as the "gold standard", swallowing process is divided into four periods: cognitive, oral, pharyngeal, and esophageal periods with a total score of 10 and a higher score indicates better swallowing ability (less dysphagia).
Measured: day 1 and day 15

Secondary outcomes (7)

Functional Oral Intake Scale
During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The FOIS assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability. In general, the result below level 6 indicates unsafe for oral intake while level 6 and above indicates that eating via mouth can be safely conducted.
Measured: day 1 and day 15
Body mass index
Weight and height will be combined to report Body mass index in kg/m^2
Measured: day 1 and day 15
Serum albumin
Serum albumin was recorded via blood routine test.(Alb, g/L)
Measured: day 1 and day 15
Hemoglobin
Hemoglobin was recorded via blood routine test.(Hb, mg/L)
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. If there was probability for potential pneumonia, patients were requested to undergo lung CT for further diagnosis
Measured: day 1 and day 15
Activities of daily living
The activities of daily living was assessed utilizing the Modified Barthel Index (MBI). Modified Barthel Index includes the following 10 subscales. For each subscale, choices encoded with the score 10, 8, 5, 2, 0 are set with the decreasing level of self-dependence, while the final total is positively correlated with Activities of daily living. Cronbach's α of questionnaire adopted is 0.916.
Measured: day 1 and day 15
World Health Organization Quality of Life Assessment Instrument Brief Version
The Quality of Life was assessed utilizing the World Health Organization Quality of Life Assessment Instrument Brief Version (WHOQOL-BREF). WHOQOL-BREF covers various aspects such as mobility, pain, emotions, personal relationships, living conditions, and access to health services, to evaluate Quality of Life. Each item is rated on a Likert scale, and the scores are transformed into a standardized score ranging from 0 to 100, with higher scores indicating better Quality of Life.
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.

1 Jan 202322 Jun 2023

First posted22 Dec 2023
Study start1 Jan 2023
Primary completion3 Jun 2023
Study completion22 Jun 2023

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 Cerebral Small Vessel DiseasesStudies 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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06179550
Sponsor's protocol ID: 2022-KY-1532
Other IDs: Zhengzhou University
Acronym: CSVD
Status last verified: Mar 2024
First submitted: 2 Dec 2023
Last updated: 15 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The datasets generated and analyzed during the current study are not publicly available due to Data Confidentiality of National Key R\&D Projects but are available from the corresponding author on reasonable request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebral Small Vessel Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Study to Explore the Clinical Effect of Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on Cerebral Small Vessel Disease Patients With Dysphagia
ClinicalTrials.gov ID: NCT06179550
Acronym / sponsor ID: CSVD / 2022-KY-1532
Conditions: Cerebral Small Vessel Diseases
Keywords: Cerebral Small Vessel Disease, Enteral Nutrition., Intermittent Oro-esophageal Tube Feeding
Study type: Interventional
Recruitment status: TerminatedReason stopped: ethical issues
Enrolment: 60 participants (actual)
Lead sponsor: Zeng ChanghaoUniversity, hospital or other
Study start: 1 Jan 2023 (actual)
Primary completion: 3 Jun 2023 (actual)
Study completion: 22 Jun 2023 (actual)
First posted: 22 Dec 2023 (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.

Detailed description

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 control group	Active comparator	Device: Nasogastric tubeAssigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: 1. Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. 2. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. 3. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. Besides, the control group was given enteral nutritional support with NGT 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\&#39;s 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 observation group	Experimental	Device: Intermittent Oro-esophageal TubeAssigned by the random number table.During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: 1. Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. 2. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. 3. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. The observation group was given enteral nutritional support with IOE according to the following procedure. The feeding content was formulated by the nutritionists based on the patient\&#39;s 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

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Clinical diagnosis of CSVD, confirmed by MRI;
Must be able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) ;
Clinical diagnosis of dysphagia through the Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS);
Age between 40 and 70 years;
Enteral nutrition support was required and feasible.

Key exclusion criteria (5 listed)

Dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases;
Complicated with severe liver and kidney failure, tumors, or hematological disorders;
Simultaneously need to undergo other therapy that might affect the outcomes of this study;
Unable or unwilling to undergo VFSS;
Pregnant or nursing females.

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
Nasogastric tubeAlso: 1) Basic treatment, including corresponding control of risk factors and education on healthy lifestyles., 2) Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training., 3) Pulmonary function training, including standing training, cough training, and diaphragm muscle training.Besides, the control group was given enteral nutritional support with NGT 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\'s 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 patient\'s 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 control group
Intermittent Oro-esophageal TubeAlso: 1) Basic treatment, including corresponding control of risk factors and education on healthy lifestyles., 2) Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training., 3) Pulmonary function training, including standing training, cough training, and diaphragm muscle training.The observation group was given enteral nutritional support with IOE according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm (Appendix). However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.	Device	The observation group

Primary outcome

Video Fluoroscopic Swallowing Study
Time frame: day 1 and day 15
Video Fluoroscopic Swallowing Study, which is considered as the "gold standard", swallowing process is divided into four periods: cognitive, oral, pharyngeal, and esophageal periods with a total score of 10 and a higher score indicates better swallowing ability (less dysphagia).

7 secondary outcomes

Functional Oral Intake Scale
Time frame: day 1 and day 15
Body mass index
Time frame: day 1 and day 15
Serum albumin
Time frame: day 1 and day 15
Hemoglobin
Time frame: day 1 and day 15
Pneumonia
Time frame: day 1 and day 15
Activities of daily living
Time frame: day 1 and day 15
World Health Organization Quality of Life Assessment Instrument Brief Version
Time frame: day 1 and day 15

Results and safety

The study was stopped early (reason given: ethical issues). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Individual participant dataSharing planned: No. The datasets generated and analyzed during the current study are not publicly available due to Data Confidentiality of National Key R\&D Projects but are available from the corresponding author on reasonable request.

Related trials for Cerebral Small Vessel Diseases

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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.

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 Nasogastric tube and Intermittent Oro-esophageal Tube in people with Cerebral Small Vessel Diseases, 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 6 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: stopped early, as of the sponsor's last update on 15 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 stopped early (reason given: ethical issues). 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?

Video Fluoroscopic Swallowing Study (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?

On the ClinicalTrials.gov record for NCT06179550.

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 15 Mar 2024.