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Effect and Complication of Two Types of Nasogastric Tube Feeding for Elderly Dysphagia Patient After Stroke

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ClinicalTrials.gov Identifier: NCT03844139
Recruitment Status : Unknown
Verified February 2020 by Second Affiliated Hospital, School of Medicine, Zhejiang University.
Recruitment status was:  Recruiting
First Posted : February 18, 2019
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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Brief Summary:
Dysphagia is a common problem after stroke.Patients after stroke with swallow problem will have a nasogastric tube to be feeded. In this study , investigators have including and excluding criteria. Continous feeding group and intermittent feeding group had been widely used in enteral nutrition feeding in investigators' institution. Investigators will observe participants' nutrition condition and tube-feeding related complications. In continous group patients, participants usually are given prescribed enteral nutrient solution using nutrition pump in 24 hours; while in intermittent feeding group, participants will be given prescribed enteral nutrient solution in 4-5 times by special syringe. During the whole process, investigators will observe all participants' nutrition condition (body mass index, plasma albumin and calf girth) and tube-feeding related complications( regurgitation, aspiration,gastric retention, diarrhea,constipation). With all those data, the investigators will assess which feeding type is better.

Condition or disease Intervention/treatment
Deglutition Disorders Device: Feeding pump and glycerin syringe

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observation of Effect and Complication of Two Types of Nasogastric Tube Feeding Enteral Nutrition for Elderly Dysphagia Patients After Stroke
Actual Study Start Date : February 13, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Glycerin

Groups and Cohorts
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Group/Cohort Intervention/treatment
Feeding pump group(continous)
Using the feeding pump to give patients prescribed enteral nutrient solution through nasogastric tube in 24 hours
 Device: Feeding pump and glycerin syringe
The continuous group use feeding pump and the intermittent group use syringe to give dysphagia patients after stroke prescribed nutrition through nasogastric tube.
Glycerin syringe group(intermittent)
Using the glycerin syringe to give patients prescribed enteral nutrient solution through nasogastric tube in 4-5 times
 Device: Feeding pump and glycerin syringe
The continuous group use feeding pump and the intermittent group use syringe to give dysphagia patients after stroke prescribed nutrition through nasogastric tube.


Outcome Measures
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Primary Outcome Measures :
  1. weight [ Time Frame: 4-6 weeks ]
    weight in kilogram every week

  2. plasma albumin [ Time Frame: 4-6 weeks ]
    plasma albumin every week

  3. tube-feeding related complications( regurgitation, aspiration,gastric retention, diarrhea,constipation) [ Time Frame: 4-6 weeks ]
    incidence of each complication


Secondary Outcome Measures :
  1. calf girth [ Time Frame: 4-6 weeks ]
    length of calf girth


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Every 50 patients in each group
Criteria

Inclusion Criteria:

  • Older than 65 years old
  • Clinical diagnosis of stroke( ischemic and hemorrhage)
  • With moderate and/or sever swallow problem(water swallow test IV-V degree)
  • With nasogastric feeding tube more than 4 weeks
  • Do rehabilitation in our hospital or designated hospitals

Exclusion Criteria:

  • Without nasogastric feeding tube
  • Patients with fever and other infection
  • Chronic or acute anoxia
  • Poor obedience
  • Quit treatment or go back home to take rehabilitation
  • Critically ill or died
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844139


Contacts
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Contact: Zhang Yuejiao, Bachelor +8613606525359 2507088@zju.edu.cn

Locations
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China, Zhejiang
Zhangy Yuejiao Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Zhangy Yuejiao         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03844139    
Other Study ID Numbers: zhang yuejiao
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
 Otorhinolaryngologic Diseases
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs