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Not yet recruitingNCT06328920Updated Mar 25, 2024

Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance for Stroke

An interventional study of Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding in Stroke, sponsored by Copka Sonpashan. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-25.

Sponsored by Copka Sonpashan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

The study will last 15 days for each participant. 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.

02

Conditions studied

  • Stroke

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03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Intermittent Oro-esophageal Tube Feeding

    The 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

    Device: Intermittent Oro-esophageal Tube Feeding

  • Active comparator
    Nasogastric Tube Feeding

    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.

    Device: Nasogastric Tube Feeding

Interventions

  • DeviceIntermittent Oro-esophageal Tube Feeding

    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.

  • DeviceNasogastric Tube Feeding

    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.

05

What researchers measure

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.

    Time frame: day 1 and day 15

Secondary outcomes

  1. Patient Health Questionnaire-9

    The total score of the Patient Health Questionnaire-9 ranges from 0 to 27, with higher scores indicating more severe depression symptoms.

    Time frame: day 1 and day 15

  2. 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.

    Time frame: day 1 and day 15

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06328920
Lead sponsor
Copka Sonpashan
Responsible party
Copka Sonpashan (The Research Director, Chao Phya Abhaibhubejhr Hospital) — Sponsor-investigator
First posted
Mar 25, 2024
Start date
Mar 2024 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 25, 2024

Study contacts

Qianyun Ce
Contact
zengxizdyfy@126.com
17839993611
Nieto Luis
study chair · Site Coordinator of United Medical Group

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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