Using the High Resolution Impedance Manometry to Evaluate Swallowing Function After Cervical Spine Surgery
1 other identifier
observational
24
0 countries
N/A
Brief 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. The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2019
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2019
CompletedFirst Posted
Study publicly available on registry
October 11, 2019
CompletedStudy Start
First participant enrolled
November 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedOctober 11, 2019
October 1, 2019
2.2 years
October 6, 2019
October 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
mean pharyngeal peak pressure
the pharyngeal presssure change during swallowing
preoperative, postoperative day 1 and 7
Study Arms (2)
anterior cervical spine surgery
The patients will be enrolled for elective anterior cervical spine surgery.
posterior cervical spine surgery
The patients will be enrolled for elective postieor cervical spine surgery
Interventions
anterior approach
posteiror appraoch
Eligibility Criteria
The patients recieved elective cervical spine surgery
You may not qualify if:
- \- 1. Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
- \. Patients who have the risk of difficult ventilation or intubation. 3. pregnant women 4. coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2019
First Posted
October 11, 2019
Study Start
November 2, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
October 11, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share