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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03844139

Collaborator

(none)

100

Enrollment

Location

22.6

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Deglutition Disorders	Device: Feeding pump and glycerin syringe

Study Design

Study Type:

Observational

Anticipated 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 :

Feb 13, 2019

Anticipated Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	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.

Arm

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

Primary Outcome Measures

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

Secondary Outcome Measures

calf girth [4-6 weeks]
length of calf girth

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Zhangy Yuejiao	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT03844139

Other Study ID Numbers:

zhang yuejiao

First Posted:

Feb 18, 2019

Last Update Posted:

Feb 13, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Deglutition Disorders

Glycerol

Study Results

No Results Posted as of Feb 13, 2020