Hypopharyngeal Pressure Changes Between Before and After Swallowing RehabiliationNCT05494515
Enhancing Early Swallowing Recovery in Older Dysphagic Patients Afetr Anterior Cervical Spine Surgery
A study testing the early swallowing rehabilitation program in people with Hypopharyngeal Pressure Changes Between Before and After Swallowing Rehabiliation, run by National Taiwan University Hospital.
Trial summary
The early swallowing rehabilitation program in older patients receiving elective surgery is regarded to enhance the recovery pf swallowing ability. However, objective evidence of changes in swallowing in older patients after ACSS, or the effect of the early rehabilitation program on recovery, is limited. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hypopharyngeal Pressure Changes Between Before and After Swallowing Rehabiliation
- What is being tested?
- the early swallowing rehabilitation program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 22 Aug 2022to 22 Aug 2028
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 60 to 80 years who underwent elective ACSS surgery
- One week after ACSS, patients with EAT-10 scores≥4
Who cannot join
- patients have major organ dysfunction, such as hemodialysis
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: Enhancing Early Swallowing Recovery of Postoperative Rehabilitation Program in Older Patients With Subjective Dysphagia After Anterior Cervical Spine Surgery: a Randomized Controlled Trial
The early swallowing rehabilitation program in older patients receiving elective surgery is regarded to enhance the recovery pf swallowing ability. However, objective evidence of changes in swallowing in older patients after ACSS, or the effect of the early rehabilitation program on recovery, is limited.
The aim of this study is that changes in hypopharyngeal muscle after ACSS will be significantly higher in older patients who underwent rehabilitation program than those who did not go through the rehabilitation program. Postoperative pulmonary complications and mortality will be followed up until 5 weeks after ACSS.
Read the detailed description
Backgrounds: The number of aging patients is increasing. Aging is associated with an increased risk of dysphagia because of cerebral atrophy, deterioration in nerve function, and a region-dependent decline in muscle mass, which affects the swallowing mechanism. During the anterior approach cervical spine (ACSS) surgery, the upper esophageal sphincter (UES) and pharyngeal muscle group, especially the hypopharynx, is suspended to allow the surgeon to approach the cervical disc. The patients have an increased risk of dysphagia because traction injury of the UES and the muscle groups of the hypopharynx is unavoidable. The early swallowing rehabilitation program in older patients receiving elective surgery is regarded to enhance the recovery pf swallowing ability. However, objective evidence of changes in swallowing in older patients after ACSS, or the effect of the early rehabilitation program on recovery, is limited.
High resolution impedance manometry (HRIM) has been developed and used for the evaluation of dysphagia. HRIM involves multiple pressure sensors that detect changes in impedance as the food bolus is transmitted through the pharyngeal region. Eating Assessment Tool (EAT-10) is the most frequently used questionnaire for screening dysphagia, where score ≥4 is abnormal. Most previous studies used subjective questionnaire to investigate changes in perioperative swallowing after ACSS. One study that used HRIM to evaluate perioperative swallowing changes in ACSS patients found a decrease in muscle strength in the hypopharyngeal muscle groups. However, the study only recruited fourteen patients, and the mean age of the patients was 59 years old.
Aim and hypothesis: Investigators aim to investigate whether early swallowing rehabilitation can be used to enhance the hypopharyngeal muscle recovery after ACSS in aged patients with subjective dysphagia (EAT-10 score ≥4). The hypothesis is that changes in hypopharyngeal muscle after ACSS will be significantly higher in older patients who underwent rehabilitation program than those who did not go through the rehabilitation program. Postoperative pulmonary complications and mortality will be followed up until 5 weeks after ACSS.
Methods: Fifteen patients aged 60 to 80 years who underwent elective ACSS surgery will be recruited. All patients will have their HRIM measurement taken and answer the EAT-10 questionnaire before surgery. One week after ACSS, patients with EAT-10 scores≥4 will have their HRIM measurements taken and be randomized into either the intervention group, who will be enrolled in the early swallowing rehabilitation program, or the routine care group. The patients in the intervention group will return to the rehabilitation clinic after participating in the rehabilitation program for two weeks, during which their compliance will be monitored by daily phone reminders with a speech therapist or research assistant. After four weeks of participating in the rehabilitation program (i.e. five weeks after surgery), all patients in both the intervention and routine care groups will have their HRIM measurement taken and answer the EAT-10 questionnaire again. Postoperative pneumonia and mortality were followed up until five weeks after surgery.
- Being tested
- the early swallowing rehabilitation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the early swallowing rehabilitation programProcedure or surgery
the early swallowing rehabilitation program based on the HRIM evaluation
| Study group | Role | What they receive |
|---|---|---|
| the early swallowing rehabilitation program | Experimental | swallowing problem eveluated by high resolution impedance manometry (HRIM). The early swallowing rehabilitation program based on the results of HRIM evaluation Receives: Procedure: the early swallowing rehabilitation program |
| the routine care group | No intervention | patients recieve swallowing education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in pre-and postoperative hypopharyngeal pressure
Measured: preoperative condition to postoperative 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start22 Aug 2022 (estimated)
- Primary completion22 Aug 2027 (estimated)
- Study completion22 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopharyngeal Pressure Changes Between Before and After Swallowing RehabiliationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups, the early swallowing rehabilitation program, or the routine care group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494515
- Sponsor's protocol ID
- 202206073RINB
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to ethical issue
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Early Swallowing Recovery of Postoperative Rehabilitation Program in Older Patients With Subjective Dysphagia After Anterior Cervical Spine Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05494515
- Acronym / sponsor ID
- 202206073RINB
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 22 Aug 2022 (estimated)
- Primary completion
- 22 Aug 2027 (estimated)
- Study completion
- 22 Aug 2028 (estimated)
- First posted
- 10 Aug 2022 (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 early swallowing rehabilitation program in older patients receiving elective surgery is regarded to enhance the recovery pf swallowing ability. However, objective evidence of changes in swallowing in older patients after ACSS, or the effect of the early rehabilitation program on recovery, is limited.
The aim of this study is that changes in hypopharyngeal muscle after ACSS will be significantly higher in older patients who underwent rehabilitation program than those who did not go through the rehabilitation program. Postoperative pulmonary complications and mortality will be followed up until 5 weeks after ACSS.
Detailed description
Backgrounds: The number of aging patients is increasing. Aging is associated with an increased risk of dysphagia because of cerebral atrophy, deterioration in nerve function, and a region-dependent decline in muscle mass, which affects the swallowing mechanism. During the anterior approach cervical spine (ACSS) surgery, the upper esophageal sphincter (UES) and pharyngeal muscle group, especially the hypopharynx, is suspended to allow the surgeon to approach the cervical disc. The patients have an increased risk of dysphagia because traction injury of the UES and the muscle groups of the hypopharynx is unavoidable. The early swallowing rehabilitation program in older patients receiving elective surgery is regarded to enhance the recovery pf swallowing ability. However, objective evidence of changes in swallowing in older patients after ACSS, or the effect of the early rehabilitation program on recovery, is limited.
High resolution impedance manometry (HRIM) has been developed and used for the evaluation of dysphagia. HRIM involves multiple pressure sensors that detect changes in impedance as the food bolus is transmitted through the pharyngeal region. Eating Assessment Tool (EAT-10) is the most frequently used questionnaire for screening dysphagia, where score ≥4 is abnormal. Most previous studies used subjective questionnaire to investigate changes in perioperative swallowing after ACSS. One study that used HRIM to evaluate perioperative swallowing changes in ACSS patients found a decrease in muscle strength in the hypopharyngeal muscle groups. However, the study only recruited fourteen patients, and the mean age of the patients was 59 years old.
Aim and hypothesis: Investigators aim to investigate whether early swallowing rehabilitation can be used to enhance the hypopharyngeal muscle recovery after ACSS in aged patients with subjective dysphagia (EAT-10 score ≥4). The hypothesis is that changes in hypopharyngeal muscle after ACSS will be significantly higher in older patients who underwent rehabilitation program than those who did not go through the rehabilitation program. Postoperative pulmonary complications and mortality will be followed up until 5 weeks after ACSS.
Methods: Fifteen patients aged 60 to 80 years who underwent elective ACSS surgery will be recruited. All patients will have their HRIM measurement taken and answer the EAT-10 questionnaire before surgery. One week after ACSS, patients with EAT-10 scores≥4 will have their HRIM measurements taken and be randomized into either the intervention group, who will be enrolled in the early swallowing rehabilitation program, or the routine care group. The patients in the intervention group will return to the rehabilitation clinic after participating in the rehabilitation program for two weeks, during which their compliance will be monitored by daily phone reminders with a speech therapist or research assistant. After four weeks of participating in the rehabilitation program (i.e. five weeks after surgery), all patients in both the intervention and routine care groups will have their HRIM measurement taken and answer the EAT-10 questionnaire again. Postoperative pneumonia and mortality were followed up until five weeks after surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- two groups, the early swallowing rehabilitation program, or the routine care group
| Arm | Type | Receives |
|---|---|---|
| the early swallowing rehabilitation program | Experimental | Procedure: the early swallowing rehabilitation programswallowing problem eveluated by high resolution impedance manometry (HRIM). The early swallowing rehabilitation program based on the results of HRIM evaluation |
| the routine care group | No intervention | –patients recieve swallowing education |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 60 to 80 years who underwent elective ACSS surgery
- One week after ACSS, patients with EAT-10 scores≥4
Key exclusion criteria (1 listed)
- patients have major organ dysfunction, such as hemodialysis
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 |
|---|---|---|
| the early swallowing rehabilitation programthe early swallowing rehabilitation program based on the HRIM evaluation | Procedure or surgery | the early swallowing rehabilitation program |
Primary outcome
The difference in pre-and postoperative hypopharyngeal pressure
Time frame: preoperative condition to postoperative 5 weeks
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 12 Aug 2022.
- Individual participant dataSharing planned: No. due to ethical issue
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 the early swallowing rehabilitation program in people with Hypopharyngeal Pressure Changes Between Before and After Swallowing Rehabiliation, 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 1 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 12 Aug 2022. 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. 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-Jun Lai, MD (0223123456, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in pre-and postoperative hypopharyngeal pressure (time frame: preoperative condition to postoperative 5 weeks). 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 12 Aug 2022.