Pharyngeal Pressure ChangeNCT04123522
Using the High Resolution Impedance Manometry to Evaluate Swallowing Function After Cervical Spine Surgery
An observational study of Pharyngeal Pressure Change, run by National Taiwan University Hospital.
Trial summary
Dysphagia is a well-known complication following cervical spine surgery, including anterior or posterior approach. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pharyngeal Pressure Change
- What is being tested?
- anterior approach and posterior appraoch
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2019to 31 Dec 2022
- 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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: The patients recieved elective cervical spine surgery
Who may be able to join
None listed.
Who cannot join
- 1. Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
- 2. Patients who have the risk of difficult ventilation or intubation. 3. pregnant women 4. coagulopathy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Using the High Resolution Impedance Manometry to Evaluate Swallowing Function After Cervical Spine Surgery: Anterior vs Posterior Approach
Dysphagia is a well-known complication following cervical spine surgery, including anterior or posterior approach. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.
The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.
Read the detailed description
Dysphagia is a well-known complication following cervical spine surgery, including anterior or posterior approach. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.
The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.
In this study, using the high resolution impedance manometry to determine (1) whether the occurrence of dysphagia in the postoperative 1 or 7 days and 1 month in the patients receiving anterior vs posterior approach of cervical spine surgery (2) which muscle in the pharyngeal region would be destroyed Consecutive patients who will fulfill the criteria of cervical spine surgery patients under general anesthesia and aged >= 20 will be enrolled. The patients would receive the dysphagia questionnaire. All subjects would receive the swallowing function by HRIM before the surgeries. The cough test was also measured. After the surgery, the patient would be followed the swallowing function in the postoperative one day, and 1 week by HRIM and questionnaire.
This study would expect (1) that the posterior cervical spine surgery would result in dysphagia greater than baseline, but less than that of anterior cervical procedures; (2) decreasing upper esophageal sphincter (UES) pressure may be the reason of postoperative dysphagia in the anterior cervical spine surgery, resulted from the intraoperative traction; (3) decreasing hypopharyngeal muscle pressure may be the reason of postoperative dysphagia in the posterior spine surgery, resulted from the prone and flexion positioning.
- Conditions
- Pharyngeal Pressure Change
- Being tested
- anterior approach, posterior appraoch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior approachProcedure or surgery
Also called anterior appraoch
anterior approach
posterior appraochProcedure or surgery
Also called posterior approach
posteiror appraoch
| Study group | Role | What they receive |
|---|---|---|
| anterior cervical spine surgery | The patients will be enrolled for elective anterior cervical spine surgery. Receives: Procedure: anterior approach | |
| posterior cervical spine surgery | The patients will be enrolled for elective postieor cervical spine surgery Receives: Procedure: posterior appraoch |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean pharyngeal peak pressure
the pharyngeal presssure change during swallowing
Measured: preoperative, postoperative day 1 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start2 Nov 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharyngeal Pressure ChangeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 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
- NCT04123522
- Sponsor's protocol ID
- 201907079RINA
- Status last verified
- Oct 2019
- First submitted
- 6 Oct 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- 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 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the High Resolution Impedance Manometry to Evaluate Swallowing Function After Cervical Spine Surgery: Anterior vs Posterior Approach
- ClinicalTrials.gov ID
- NCT04123522
- Acronym / sponsor ID
- 201907079RINA
- Conditions
- Pharyngeal Pressure Change
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Nov 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Oct 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 well-known complication following cervical spine surgery, including anterior or posterior approach. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.
The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.
Detailed description
Dysphagia is a well-known complication following cervical spine surgery, including anterior or posterior approach. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.
The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.
In this study, using the high resolution impedance manometry to determine (1) whether the occurrence of dysphagia in the postoperative 1 or 7 days and 1 month in the patients receiving anterior vs posterior approach of cervical spine surgery (2) which muscle in the pharyngeal region would be destroyed Consecutive patients who will fulfill the criteria of cervical spine surgery patients under general anesthesia and aged >= 20 will be enrolled. The patients would receive the dysphagia questionnaire. All subjects would receive the swallowing function by HRIM before the surgeries. The cough test was also measured. After the surgery, the patient would be followed the swallowing function in the postoperative one day, and 1 week by HRIM and questionnaire.
This study would expect (1) that the posterior cervical spine surgery would result in dysphagia greater than baseline, but less than that of anterior cervical procedures; (2) decreasing upper esophageal sphincter (UES) pressure may be the reason of postoperative dysphagia in the anterior cervical spine surgery, resulted from the intraoperative traction; (3) decreasing hypopharyngeal muscle pressure may be the reason of postoperative dysphagia in the posterior spine surgery, resulted from the prone and flexion positioning.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anterior cervical spine surgery | – | Procedure: anterior approachThe patients will be enrolled for elective anterior cervical spine surgery. |
| posterior cervical spine surgery | – | Procedure: posterior appraochThe patients will be enrolled for elective postieor cervical spine surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients recieved elective cervical spine surgery
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 1. Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
- 2. Patients who have the risk of difficult ventilation or intubation. 3. pregnant women 4. coagulopathy
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 |
|---|---|---|
| anterior approachAlso: anterior appraochanterior approach | Procedure or surgery | anterior cervical spine surgery |
| posterior appraochAlso: posterior approachposteiror appraoch | Procedure or surgery | posterior cervical spine surgery |
Primary outcome
mean pharyngeal peak pressure
Time frame: preoperative, postoperative day 1 and 7
the pharyngeal presssure change during swallowing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharyngeal Pressure Change, 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 0 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: status not confirmed, as of the sponsor's last update on 11 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Jun Lai, MD (23123456, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean pharyngeal peak pressure (time frame: preoperative, postoperative day 1 and 7). 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 11 Oct 2019.