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

Observation of Effect and Complication of Two Types of Nasogastric Tube Feeding Enteral Nutrition for Elderly Dysphagia Patients After Stroke

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.

Study Overview

• Status: Unknown
• Conditions: Deglutition Disorders
• Intervention / Treatment: Device: Feeding pump and glycerin syringe

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Zhang Yuejiao, Bachelor; Phone Number: +8613606525359; Email: 2507088@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Zhangy Yuejiao
      • Contact: Zhangy Yuejiao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Every 50 patients in each group

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	weight in kilogram every week	4-6 weeks
plasma albumin	plasma albumin every week	4-6 weeks
tube-feeding related complications( regurgitation, aspiration,gastric retention, diarrhea,constipation)	incidence of each complication	4-6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
calf girth	length of calf girth	4-6 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders; Physiological Effects of Drugs; Protective Agents; Cryoprotective Agents; Glycerol
• Other Study ID Numbers: zhang yuejiao

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No