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

Deglutition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03844139
• Other study ID #: zhang yuejiao
• Status: Recruiting
• Start date: February 13, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Zhang Yuejiao, Bachelor
• Phone: +8613606525359
• Email: 2507088[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders

Intervention

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.

Locations

Country	Name	City	State
China	Zhangy Yuejiao	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight	weight in kilogram every week	4-6 weeks
Primary	plasma albumin	plasma albumin every week	4-6 weeks
Primary	tube-feeding related complications( regurgitation, aspiration,gastric retention, diarrhea,constipation)	incidence of each complication	4-6 weeks
Secondary	calf girth	length of calf girth	4-6 weeks