DysphagiaNCT02822456
Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing
A study testing VFSS in people with Dysphagia, run by Ulsan University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to test the clinical effectiveness of IOE tube using individually customized 3-dimentional printed guiding tube as an alternative to Levin tube feeding when unconscious patients have no choice but tube feeding. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dysphagia
- What is being tested?
- VFSS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to Dec 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dysphagia patients to check in VFSS (videofluoroscopic swallow study)
- Patients participating in the study agreement
- Oral feeding is not possible (Need tube feeding)
Who cannot join
- Patient to reject the participation
- Crico-pharyngeal incoordination
- Impaired esophageal peristalsis
- Impaired GI tract
- Observed esophageal reflux
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ulsan University Hospital
Ulsan, 682-714
Chang Ho Hwang, M.D., Ph.D., +82-52-250-7210, chhwang1220ciba@gmail.com
Chang Ho Hwang, M.D., Ph.D.
About this study
Official title: Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing: Prospective, Single Center, Observational Trial of Superiority
The aim of this study is to test the clinical effectiveness of IOE tube using individually customized 3-dimentional printed guiding tube as an alternative to Levin tube feeding when unconscious patients have no choice but tube feeding.
Read the detailed description
According to standard Guideine of videofluoroscopic swallow study(VFSS), Patients referred to dysphagia(swallowing dysfunction)who were required to tube feeding and medically stable of vital sign, and agreed to participate. Participants with swallowing dysfunction who were classified into three groups (nasogastric tube, traditional intermittent (IOE) tube, individual 3D printed guiding tube) according to VFSS.
Both traditional IOE tube and individual 3D printed guiding tube groups will receive training about procedure prior to the first feeding. All participants will be evaluated with satisfaction for tube feeding (EORTC QLQ-H\&N35) in 3 days from the start day of the tube feeding. On the day of oral feeding, participants will be evaluated with the questionnaires and clinical examination. If the participant is discharged in a state maintain the tube feeding, investigated further length stay at leaving the hospital. On the 1 month, 3 month from tube feeding, the investigators will follow-up and measure the questionnaires and clinical examination.
- Conditions
- Dysphagia
- Being tested
- VFSS
- Keywords
- dysphagia, intermittent tube, individual 3D printed guiding tube
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VFSSProcedure or surgery
VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube
| Study group | Role | What they receive |
|---|---|---|
| Individual 3D-printed guided tube | Experimental | IOE tube feeding using individual 3D-printed guided tube and nelaton tube whenever they eat Receives: Procedure: VFSS |
| traditional IOE tube | Active comparator | classic IOE tube feeding using nelaton tube only whenever they eat Receives: Procedure: VFSS |
| nasogastric tube | Active comparator | nasogastric tube feeding using levin tube always Receives: Procedure: VFSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of EORTC QLQ - H&N35 index
Details (inconvenience, discomfort, altered body image, social activities, family life, pain, ease of learning to use) satisfaction evaluation (3, 9, 10)
Measured: 1 month after start of tube feeding
Secondary outcomes (6)
complications
whether aspiration pneumonia on Chest Radiography or not, Measurement at leave hospital or start oral feeding can be another endpoint
Measured: after 1st session (3days) and after 1 month, and after 3 months
change Mid-arm circumference
Measured: before VFSS and 1 month and 3 months after start of tube feeding
change of Serum albumin
Measured: before VFSS and 1 month and 3 months after start of tube feeding
change of MRS index
Measured: before VFSS and 1 month and 3 months after start of tube feeding
change of success rate (rate of elimination)
Measured: after 1st session (3days), after 1 month, and after 3 months
change of EORTC QLQ - H&N35 index
Measurement at leave hospital or start oral feeding can be another endpoint, Details (inconvenience, discomfort, altered body image, social activities, family life, pain, ease of learning to use) satisfaction evaluation (3, 9, 10)
Measured: after 1st session (3days) and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Ho Hwang, Ulsan University Hospital
- Investigators
- Chang Ho Hwang, M.D., Ph.D., Study director, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822456
- Sponsor's protocol ID
- chhwang5
- Status last verified
- Dec 2019
- First submitted
- 14 Jun 2016
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing: Prospective, Single Center, Observational Trial of Superiority
- ClinicalTrials.gov ID
- NCT02822456
- Acronym / sponsor ID
- chhwang5
- Conditions
- Dysphagia
- Keywords
- dysphagia, intermittent tube, individual 3D printed guiding tube
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Jul 2016 (estimated)
- 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.
The aim of this study is to test the clinical effectiveness of IOE tube using individually customized 3-dimentional printed guiding tube as an alternative to Levin tube feeding when unconscious patients have no choice but tube feeding.
Detailed description
According to standard Guideine of videofluoroscopic swallow study(VFSS), Patients referred to dysphagia(swallowing dysfunction)who were required to tube feeding and medically stable of vital sign, and agreed to participate. Participants with swallowing dysfunction who were classified into three groups (nasogastric tube, traditional intermittent (IOE) tube, individual 3D printed guiding tube) according to VFSS.
Both traditional IOE tube and individual 3D printed guiding tube groups will receive training about procedure prior to the first feeding. All participants will be evaluated with satisfaction for tube feeding (EORTC QLQ-H\&N35) in 3 days from the start day of the tube feeding. On the day of oral feeding, participants will be evaluated with the questionnaires and clinical examination. If the participant is discharged in a state maintain the tube feeding, investigated further length stay at leaving the hospital. On the 1 month, 3 month from tube feeding, the investigators will follow-up and measure the questionnaires and clinical examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual 3D-printed guided tube | Experimental | Procedure: VFSSIOE tube feeding using individual 3D-printed guided tube and nelaton tube whenever they eat |
| traditional IOE tube | Active comparator | Procedure: VFSSclassic IOE tube feeding using nelaton tube only whenever they eat |
| nasogastric tube | Active comparator | Procedure: VFSSnasogastric tube feeding using levin tube always |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Dysphagia patients to check in VFSS (videofluoroscopic swallow study)
- Patients participating in the study agreement
- Oral feeding is not possible (Need tube feeding)
Key exclusion criteria (5 listed)
- Patient to reject the participation
- Crico-pharyngeal incoordination
- Impaired esophageal peristalsis
- Impaired GI tract
- Observed esophageal reflux
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 |
|---|---|---|
| VFSSVFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube | Procedure or surgery | Individual 3D-printed guided tube, nasogastric tube, traditional IOE tube |
Primary outcome
change of EORTC QLQ - H&N35 index
Time frame: 1 month after start of tube feeding
Details (inconvenience, discomfort, altered body image, social activities, family life, pain, ease of learning to use) satisfaction evaluation (3, 9, 10)
6 secondary outcomes
complications
Time frame: after 1st session (3days) and after 1 month, and after 3 months
change Mid-arm circumference
Time frame: before VFSS and 1 month and 3 months after start of tube feeding
change of Serum albumin
Time frame: before VFSS and 1 month and 3 months after start of tube feeding
change of MRS index
Time frame: before VFSS and 1 month and 3 months after start of tube feeding
change of success rate (rate of elimination)
Time frame: after 1st session (3days), after 1 month, and after 3 months
change of EORTC QLQ - H&N35 index
Time frame: after 1st session (3days) and after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- 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.
Chang Ho Hwang, M.D., Ph.D. study director
Ulsan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VFSS in people with Dysphagia, run by Ulsan University Hospital at 1 site in South Korea.
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 3 inclusion and 5 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 3 Dec 2019. 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 South Korea. 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 Chang Ho Hwang (+82-52-250-8898, chhwang1220ciba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of EORTC QLQ - H&N35 index (time frame: 1 month after start of tube feeding). 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 3 Dec 2019.