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Clinical Trials/NCT06211777
NCT06211777
Withdrawn
Not Applicable

Effect of Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on Dysphagia Patients After Stroke: A Prospective Multicenter Study

Zeng Changhao1 site in 1 countryJanuary 10, 2024
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Zeng Changhao
Locations
1
Primary Endpoint
Penetration-Aspiration Scale
Status
Withdrawn
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2024
End Date
April 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zeng Changhao
Responsible Party
Sponsor Investigator
Principal Investigator

Zeng Changhao

Research Director

People's Hospital of Zhengzhou University

Eligibility Criteria

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.

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)
  • Patient health questionnaire-9(day 1 and day 15)
  • Swallowing Quality of Life questionnaire(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)

Study Sites (1)

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