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
Phase: NA
Conditions: Cerebral Small Vessel Diseases
Sponsor: Zeng Changhao

                   
 
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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 
 
 
Plan number 
 
Version 
V1.0 
Date 
Research unit 
2022.12.1 
Department of Rehabilitation Medicine, 
The First Affiliated Hospital of Zhengzhou 
University 
Main Researchers 
Zengxi 
Research responsible unit The First Affiliated Hospital of Zhengzhou 
University 
Applicant 
Department of Rehabilitation Medicine, 
The First Affiliated Hospital of Zhengzhou 
University 
 
 
Statement 
This trial protocol is confidential and intended for distribution to medical experts, researchers 
involved in the trial, and other staff members associated with the trial, as well as the medical 
institutions, ethics committees, and contracted research organizations involved in the trial. Except 
for providing information to the participants, no content of this trial protocol shall be disclosed or 
made available to any third party without prior written consent from the sponsor. Furthermore, any 
partial or complete results of this clinical trial, when published externally in societies, journals, 
etc., require written consent from the sponsor. 
 

                   
 
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CATALOGUE 
Abstract ...................................................................................................... 3 
1、Background ......................................................................................... 5 
2、Objectiv ................................................................................................ 5 
3、Plan ....................................................................................................... 5 
4、Eligibility .............................................................................................. 5 
4.1 Inclusion criteria and exclusion criteria .......................................... 6 
4.2 Dropout and termination criteria ..................................................... 6 
4.3 Dropout and termination criteria .................................................... 6 
5、Management ........................................................................................ 7 
5.1 Ethnics and informed consent ......................................................... 7 
5.2 Protection ........................................................................................ 7 
5.3 Management unit ............................................................................ 8 
6、References ............................................................................................ 8 
Co-organizer 
N/A 

                
 
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Abstract 
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 
Drugs 
N/A 
Approval 
number 
of durgs 
N/A 
Aims 
This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients 
with Dysphagia.  
Design 
This was a randomized controlled study 
Indicatio
ns 
CSVD Patients with Dysphagia 
Total 
cases 
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) 
Center 
The First Affiliated Hospital of Zhengzhou University 
Research 
period 
2023.1-2023.6 
Case 
selection 
The inclusion criteria were: 1) Meeting the diagnostic criteria for CSVD, 
confirmed by MRI; 2) Able to cooperate with treatment and questionnaire 
investigation, (Generally with a Mini-Mental State Examination (MMSE) score 
≥ 24) ; 3) Diagnosed with dysphagia through the Functional Oral Intake Scale 
(FOIS) and Video Fluoroscopic Swallowing Study (VFSS); 4) Aged between 40 
and 70 years; 5) Enteral nutrition support was required and feasible. 5) No 
history of prior stroke. 
Study 
drug 
N/A 
Plan 
During the treatment period, both groups of patients received conventional 
treatment and enteral nutrition support. Conventional treatment included health 

                
 
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education, dietary adjustments, control of risk factors (blood pressure, lipids, 
etc.), and psychological support. The observation group used IOE for enteral 
nutrition support. The control group's nutritional support was administered via 
NGT. 
Visit 
timing 
N/A 
Procedur
es 
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. 
Assessme
nt 
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. 
Safety 
indicator 
AEs 
 
 
1.Background 
Cerebral small vessel disease (CSVD) refers to a heterogeneous group of pathological 
changes affecting the small arteries, arterioles, capillaries, venules, and small veins within the 
brain. These changes are attributed to various etiological factors[1]. According to a study 
conducted in Rotterdam, it has been observed that CSVD comprised a significant proportion, 
specifically 83.8%, of all cases of cerebrovascular diseases while epidemiological surveys have 
revealed that approximately half of the incidence of dementia and 25% of ischemic strokes can be 
attributed to cerebral small vessel disease[2, 3]. Radiologically, CSVD is characterized by 
enlarged perivascular spaces, cortical subcortical infarcts, white matter lesions, microbleeds, and 
cerebral atrophy observed on magnetic resonance imaging (MRI)[4]. According to the previous 
study, it has been demonstrated that CSVD patients exhibit an insidious onset with diverse clinical 
presentations, encompassing symptoms such as dysphagia, cognitive impairment, anxiety, and 
depression. Notably, in China, approximately 25% of CSVD patients experience varying degrees 
of dysphagia, mainly in the cognitive, oral, and pharyngeal phases[5]. 
The occurrence of subcortical lacunar infarction in the brain can give rise to a range of 
lacunar syndromes. When the pathological changes involve the knee of the internal capsule and 
basal part of the brainstem, it can lead to dysphagia in the oral and pharyngeal phrase[6]. 
Furthermore, CSVD-related negative psychological state may also cause dysphagia in the 
cognitive phrase. Besides, it has been reported that approximately 60% of individuals with CSVD 
experienced limb movement disorder, which can also contribute to the development of 
dysphagia[5]. In patients with dysphagia, various complications may arise, including aspiration, 
pneumonia, progressive weight loss, malnutrition, edema, impaired gastrointestinal absorption 

                
 
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function, and psychological and social communication disorders[7]. Hence, comprehensive and 
individualized treatment plan should be conducted for CSVD patients with dysphagia. 
Nevertheless, during the initial phase of hospitalization, it is frequently observed that patients' 
swallowing function is inadequate to sustain oral intake. Consequently, tube feeding presents 
itself as a temporary solution to provide patients with essential nutritional support especially at the 
early stage, which forms the backbone of the overall treatment process, and therefore, its selection 
is critical[8]. 
Currently, for CSVD patients with dysphagia, the primary nutritional supports available are 
enteral nutrition and parenteral nutrition[9]. Parenteral nutrition involves intravenous 
administration of essential nutrients, ensuring rapid nourishment for patients in the short term. 
Nonetheless, prolonged reliance on this method may disrupt gastrointestinal function and lead to 
gastrointestinal disturbances[10]. Enteral nutrition mainly encompasses NGT and gastrostomy, 
with each approach has its own disadvantages[11]. Both NGT and gastrostomy are viable options 
in the short term. However, prolonged use can result in various complications including 
gastroesophageal reflux, pharyngitis, aspiration pneumonia and electrolyte imbalances[12]. In 
China, due to the invasive nature of gastrostomy, patients generally exhibit lower acceptance[13]. 
Moreover, NGT poses a risk of recurrent pneumonia, significantly impacting the patient's 
functional recovery and potentially leading to increased risk of anxiety and depression[14]. 
Therefore, the selection of a secure and comfortable approach becomes paramount. 
IOE, as an alternative enteral nutrition mode, was introduced in the "Expert Consensus on 
Assessment and Treatment of Swallowing Disorders in China" in 2017[15]. It was pointed out 
that IOE maintains the normal physiological structure of the digestive tract with its intermittent 
insertion mode, which is safe, simple, and less likely to cause mucosal damage[16]. In recent 
years, the practice of IOE has gradually increased in China, and it has achieved satisfying clinical 
results in improving nutritional status[17]. However, the application of IOE in CSVD patients is 
relatively insufficient, and further research is needed to explore the relationship between IOE and 
ADL, QOL.  
2.Objective     
Therefore, this study was carried out to explore the clinical effect of IOE vs. NGT in CSVD 
patients with dysphagia, mainly on nutritional status, swallowing function, pneumonia, ADL and 
QOL. 
3.Design 
3.Type：This was a multicenter randomized controlled study 
3.2 Study patient population 
This was a multicenter randomized controlled study, including CSVD patients with 
dysphagia who received comprehensive rehabilitation therapy in the department of rehabilitation 
medicine from 3 hospitals in China from January 2023 to June 2023. Through literature review, it 
was found that when estimating the expected sample size using VFSS as an indicator of dysphagia, 
the maximum target sample size was achieved. In this case, M1=7.96, M2=6.51, S=1.90, α= 0.05, 
(1-β) =80%, it was calculated the following: 
N1= N2 = \frac[{2 \times (Z_{\alpha/2} + Z_{\beta})^2 \times S^2}][{(M1 - M2)^2}]≈27 
To assume a 10% dropout rate, the estimated sample size for this study was calculated as 
27*110%, which is approximately 30. 
A total number of 60 CSVD patients with dysphagia was finally enrolled. With a random number 
table, cases enrolled were divided into the observation group (with IOE, n=30) and the control 
group (with NGT, n=30). 
3.3Intervention 
During the treatment, all patients were provided with comprehensive rehabilitation therapy 

                
 
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as follows: 
1) Basic treatment, including corresponding control of risk factors and education on healthy 
lifestyles. 
2) Swallowing training, including lemon ice stimulation, Mendelsohn 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[18]. 
The observation group was given enteral nutritional support with IOE according to the 
following procedure[19]: 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. After each feeding, the nutrition tube was removed and placed in a container 
filled with 20% solution of vinegar for rinsing and storage. For patients with sensitive pharyngeal 
reflex, a small amount of 2% Lidocaine can be applied to the pharyngeal area for surface 
anesthesia before tube insertion.  
 
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[18]. 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. 
 
4、Case selection 
4.1 The inclusion and exclusion criteria 
The inclusion criteria were: 1) Meeting the diagnostic criteria for CSVD, confirmed by MRI; 
2) Able to cooperate with treatment and questionnaire investigation, (Generally with a 
Mini-Mental State Examination (MMSE) score ≥ 24) ; 3) Diagnosed with dysphagia through the 
Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS); 4) Aged 
between 40 and 70 years; 5) Enteral nutrition support was required and feasible. 5) No history of 
prior stroke. The exclusion criteria were: 1) With dysphagia related to other cerebrovascular 
diseases or caused by neurodegenerative diseases; 2) Complicated with severe liver and kidney 
failure, tumors, or hematological disorders; 3) Simultaneously in need to undergo other therapy 
that might affect the outcomes of this study; 4) Unable or unwilling to undergo VFSS; 5) pregnant 
or nursing females.  
4.2 The dropout criteria 
Dropout and termination criteria were: 1) a patient or family members requested to withdraw 
voluntarily; 2) development of intolerance; 3) emergence of unexpected events requiring 
adjustment of treatment. 4) the patient’s condition deteriorated severely. 

                
 
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4.3 Termination criteria 
If more than half of the subjects experience mild or higher adverse reactions (such as 3/6, 
4/8), the trial should be terminated. 
5、Study management 
5.1 Ethical Considerations and Informed Consent 
5.1.1 Approval by an Independent Ethics Committee 
Prior to the commencement of the trial, the researcher/research institution should obtain 
written approval from the independent ethics committee regarding the trial protocol, informed 
consent form, subject recruitment procedures, and any other written materials to be provided to 
the subjects. During the course of the trial, if there are any additions or revisions to the trial 
protocol, informed consent form, etc., written approval from the independent ethics committee 
should be obtained again. 
5.1.2 Informed Consent 
The researcher or their designated representative will be responsible for explaining the 
background of the study, the pharmacological characteristics of the investigational medication, the 
trial protocol, as well as the potential benefits and risks of participating in the trial to each subject, 
the subject's legally authorized representative, or witness. They should obtain written informed 
consent signed by the subject or their legally authorized representative and the investigator before 
the subject enters the trial (before screening). 
The final text of the informed consent form should include the following: the purpose of the 
trial, trial procedures, the subject's obligations, the foreseeable benefits and risks and 
inconveniences of participating in the trial, treatment and appropriate insurance compensation 
available to the subject in case of trial-related harm, access to trial data, and confidentiality of 
subject information. 
The informed consent form should obtain written approval from the ethics committee and be 
written in a language that is understandable to the subject. The subject or their legally authorized 
representative, the researcher conducting the informed consent process, or their representative 
should all sign and date the informed consent form. The original copy of the informed consent 
form should be retained by both the researcher and the subject. If important new information 
related to the investigational drug in a clinical trial is discovered, the informed consent form must 
be modified in writing, submitted for approval to the ethics committee, and re-obtained from the 
subject. 
5.2 Protection 
Prior to the start of the clinical trial, the trial protocol must be reviewed and approved by the 
ethics committee of the responsible research institution before implementation. Any modifications 
to the trial protocol during the course of the clinical trial should also be approved by the ethics 
committee before they can be executed. 
Clinical researchers must inform subjects that participation in the clinical trial is voluntary 
and that they have the right to withdraw from the trial at any stage without facing discrimination 
or retaliation. Subjects must be made aware that their participation in the trial and their personal 
information will be kept confidential. They should also be informed about the nature of the 
clinical trial, the trial objectives, the potential anticipated benefits, and the possible risks and 
inconveniences. Subjects should be informed of their rights and obligations as outlined in the 
Helsinki Declaration, and given sufficient time to consider whether they wish to participate in the 
trial. 
5.3 Management Unit 
This study will be conducted at the First Affiliated Hospital of Zhengzhou University and 
will be overseen by the ethics committee of the hospital and the clinical trial institution. 

                
 
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