Deglutition DisordersNCT03844139
Effect and Complication of Two Types of Nasogastric Tube Feeding for Elderly Dysphagia Patient After Stroke
An observational study of Deglutition Disorders, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Deglutition Disorders
- What is being tested?
- Feeding pump and glycerin syringe
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Every 50 patients in each group
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhangy Yuejiao
Hangzhou, Zhejiang, 310009
Zhangy Yuejiao
About this study
Official title: 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.
- Conditions
- Deglutition Disorders
- Being tested
- Feeding pump and glycerin syringe
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding pump and glycerin syringeDevice
The continuous group use feeding pump and the intermittent group use syringe to give dysphagia patients after stroke prescribed nutrition through nasogastric tube.
| Study group | Role | What they receive |
|---|---|---|
| Feeding pump group(continous) | Using the feeding pump to give patients prescribed enteral nutrient solution through nasogastric tube in 24 hours Receives: Device: Feeding pump and glycerin syringe | |
| Glycerin syringe group(intermittent) | Using the glycerin syringe to give patients prescribed enteral nutrient solution through nasogastric tube in 4-5 times Receives: Device: Feeding pump and glycerin syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
weight in kilogram every week
Measured: 4-6 weeks
plasma albumin
plasma albumin every week
Measured: 4-6 weeks
tube-feeding related complications( regurgitation, aspiration,gastric retention, diarrhea,constipation)
incidence of each complication
Measured: 4-6 weeks
Secondary outcomes (1)
calf girth
length of calf girth
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start13 Feb 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844139
- Sponsor's protocol ID
- zhang yuejiao
- Status last verified
- Feb 2020
- First submitted
- 1 Feb 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Effect and Complication of Two Types of Nasogastric Tube Feeding Enteral Nutrition for Elderly Dysphagia Patients After Stroke
- ClinicalTrials.gov ID
- NCT03844139
- Acronym / sponsor ID
- zhang yuejiao
- Conditions
- Deglutition Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feeding pump group(continous) | – | Device: Feeding pump and glycerin syringeUsing the feeding pump to give patients prescribed enteral nutrient solution through nasogastric tube in 24 hours |
| Glycerin syringe group(intermittent) | – | Device: Feeding pump and glycerin syringeUsing the glycerin syringe to give patients prescribed enteral nutrient solution through nasogastric tube in 4-5 times |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Every 50 patients in each group
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeding pump and glycerin syringeThe continuous group use feeding pump and the intermittent group use syringe to give dysphagia patients after stroke prescribed nutrition through nasogastric tube. | Device | Feeding pump group(continous), Glycerin syringe group(intermittent) |
Primary outcome
weight
Time frame: 4-6 weeks
weight in kilogram every week
plasma albumin
Time frame: 4-6 weeks
plasma albumin every week
tube-feeding related complications( regurgitation, aspiration,gastric retention, diarrhea,constipation)
Time frame: 4-6 weeks
incidence of each complication
1 secondary outcome
calf girth
Time frame: 4-6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Yuejiao, Bachelor (+8613606525359, 2507088@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: 4-6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.