Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on Dysphagia Patients After Stroke: A Prospective Multicenter Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- Penetration-Aspiration Scale
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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.
Arms & Interventions
Intermittent Oro-esophageal Tube Feeding+comprehensive rehabilitation therapy
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.
Intervention: Intermittent Oro-esophageal Tube Feeding (Device)
comprehensive rehabilitation therapy+Nasogastric Tube Feeding
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.
Intervention: Nasogastric Tube Feeding (Device)
Intermittent Oro-esophageal Tube Feeding+comprehensive rehabilitation therapy
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.
Intervention: comprehensive rehabilitation therapy (Behavioral)
comprehensive rehabilitation therapy+Nasogastric Tube Feeding
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.
Intervention: comprehensive rehabilitation therapy (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Nutritional status-total protein(day 1 and day 15)
- Body weight(day 1 and day 15)
- Nutritional status-albumin(day 1 and day 15)
- Yale pharyngeal residue severity rating scale(day 1 and day 15)
- Patient health questionnaire-9(day 1 and day 15)
- Swallowing Quality of Life questionnaire(day 1 and day 15)
Investigators
Copka Sonpashan
The Research Director
Chao Phya Abhaibhubejhr Hospital