The Upper Esophageal Sphincter Contraction StrengthNCT05999786
ERAS Swallowing Rehabilitation in Elder Patients
A study testing early rehabiliation swallowing program and not receiving early rehabilitation swallowing program in people with The Upper Esophageal Sphincter Contraction Strength, run by National Taiwan University Hospital.
Trial summary
The investigators studied that swallowing function of patients receiving the Early Recovery Accelerated Swallowing (ERAS-W program) training will recover fast than that of patients in the control group. The ERAS program training will be initiated before surgery and continue to after surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- The Upper Esophageal Sphincter Contraction Strength
- What is being tested?
- early rehabiliation swallowing program and not receiving early rehabilitation swallowing program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2023to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective surgery
- general anesthesia with endotracheal intubation
Who cannot join
- major organ dysfunction, ex: chronic kidney disease, hear failure
- bleeding tendency
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectivity of Early Recovery Accelerated Swallowing Program on Promoting Swallowing Recovery in Older Patients With High Risk of Oral Frailty Requiring Endotracheal Intubation During General Anesthesia: a Pilot Randomized Control Trial
The investigators studied that swallowing function of patients receiving the Early Recovery Accelerated Swallowing (ERAS-W program) training will recover fast than that of patients in the control group. The ERAS program training will be initiated before surgery and continue to after surgery.
Read the detailed description
The older patients (≥65 years old) with OFI-8≥4 undergoing elective orthopedic surgery requiring tracheal intubation will be recruited. Patients will be randomized into an intervention and a control group. Patients in the intervention groups will received the ERAS-W program, while those in the control group will receive the swallowing education video.
- Being tested
- early rehabiliation swallowing program, not receiving early rehabilitation swallowing program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early rehabiliation swallowing programBehavioural
not receiving early rehabilitation swallowing program from before and after surgery
not receiving early rehabilitation swallowing programBehavioural
the Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is from before and after surgery
| Study group | Role | What they receive |
|---|---|---|
| patients receiving early rehabiliation swallowing program | Active comparator | the early rehabilitation program beginning from before to after surgery Receives: Behavioral: early rehabiliation swallowing program |
| patients not receiving early rehabilitation swallowing program | Placebo comparator | the Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is started from before to after surgery Receives: Behavioral: not receiving early rehabilitation swallowing program |
What is being measured
The primary outcome is the main question the study is designed to answer.
UES pressure, mmHg
Measured: about six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start10 Aug 2023 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Upper Esophageal Sphincter Contraction StrengthStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients receive early recovery of swallowing rehabiliation before surgery and continued to after surgery
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999786
- Sponsor's protocol ID
- 202303005RIND
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to ethical problem
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of Early Recovery Accelerated Swallowing Program on Promoting Swallowing Recovery in Older Patients With High Risk of Oral Frailty Requiring Endotracheal Intubation During General Anesthesia: a Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05999786
- Acronym / sponsor ID
- 202303005RIND
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Aug 2023 (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.
The investigators studied that swallowing function of patients receiving the Early Recovery Accelerated Swallowing (ERAS-W program) training will recover fast than that of patients in the control group. The ERAS program training will be initiated before surgery and continue to after surgery.
Detailed description
The older patients (≥65 years old) with OFI-8≥4 undergoing elective orthopedic surgery requiring tracheal intubation will be recruited. Patients will be randomized into an intervention and a control group. Patients in the intervention groups will received the ERAS-W program, while those in the control group will receive the swallowing education video.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients receive early recovery of swallowing rehabiliation before surgery and continued to after surgery
| Arm | Type | Receives |
|---|---|---|
| patients receiving early rehabiliation swallowing program | Active comparator | Behavioral: early rehabiliation swallowing programthe early rehabilitation program beginning from before to after surgery |
| patients not receiving early rehabilitation swallowing program | Placebo comparator | Behavioral: not receiving early rehabilitation swallowing programthe Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is started from before to after surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective surgery
- general anesthesia with endotracheal intubation
Key exclusion criteria (2 listed)
- major organ dysfunction, ex: chronic kidney disease, hear failure
- bleeding tendency
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 |
|---|---|---|
| early rehabiliation swallowing programnot receiving early rehabilitation swallowing program from before and after surgery | Behavioural | patients receiving early rehabiliation swallowing program |
| not receiving early rehabilitation swallowing programthe Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is from before and after surgery | Behavioural | patients not receiving early rehabilitation swallowing program |
Primary outcome
UES pressure, mmHg
Time frame: about six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No. due to ethical problem
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.
Questions about this trial
What is this clinical trial studying?
A study testing early rehabiliation swallowing program and not receiving early rehabilitation swallowing program in people with The Upper Esophageal Sphincter Contraction Strength, run by National Taiwan University Hospital.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Min Liu, MD (_886-972652224, lewisliu@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UES pressure, mmHg (time frame: about six months). 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 21 Aug 2023.