Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Mar 2024
Shorter than P25 for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedMarch 12, 2024
March 1, 2024
4 months
February 27, 2024
March 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Rehabilitation Treatment Compliance Questionnaire
The Rehabilitation Treatment Compliance Questionnaire assesses patient compliance with rehabilitation treatment plans. It consists of 12 items that cover aspects such as the patient's understanding of the treatment plan, attitude towards treatment, compliance, and perception of rehabilitation outcomes. The scoring range for The Rehabilitation Treatment Compliance Questionnaire is typically from 12 to 60 points. A higher score indicates better understanding of the treatment plan, more positive attitude towards treatment, higher compliance with the treatment plan, and better perception of rehabilitation outcomes.
day 1 and day 15
Secondary Outcomes (2)
Patient Health Questionnaire-9
day 1 and day 15
Swallowing Quality of Life questionnaire
day 1 and day 15
Study Arms (2)
the observation group
EXPERIMENTALThe observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure. The feeding content was formulated by the nutritionists based on the 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
the control group
ACTIVE COMPARATORthe control group was given enteral nutritional support with Nasogastric Tube 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 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.
Interventions
The observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube 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.
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's cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zeng Changhaolead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nieto Luis, Master
Site Coordinator of United Medical Group located in Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Director
Study Record Dates
First Submitted
February 27, 2024
First Posted
March 7, 2024
Study Start
March 1, 2024
Primary Completion
July 1, 2024
Study Completion
July 1, 2024
Last Updated
March 12, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share