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Clinical Trials/NCT03891940
NCT03891940
Unknown
Not Applicable

Evaluation of Changes of Swallowing Motor Function After Cervical Spine Surgery With Anterior Approach- the Implication of High Resolution Impedance Manometry

National Taiwan University Hospital0 sites30 target enrollmentMarch 26, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients Receiving Anterior Cervical Spine Surgery
Sponsor
National Taiwan University Hospital
Enrollment
30
Primary Endpoint
upper esophageal sphincter pressure changes
Last Updated
7 years ago

Overview

Brief Summary

Dysphagia is a well-known complication following anterior cervical spine surgery. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.

The ultrasonography was used to measure the oropharyngeal swallowing function. The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.

we aimed to observe the changes and recovery course swallowing function parameters during the preoperative and postoperative period in the patients receiving anterior cervical spine surgery by HRIM and ultrasonography.

Detailed Description

Dysphagia is a well-known complication following anterior cervical spine surgery. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown. The ultrasonography was used to measure the oropharyngeal swallowing function. The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function. We aimed to observe the changes and recovery course swallowing function parameters during the preoperative and postoperative period in the patients receiving anterior cervical spine surgery by HRIM and ultrasonography. 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 ultrasonography and 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, 1 week, and 1 months, 3 months (If needed) by HRIM and ultrasonography.

Registry
clinicaltrials.gov
Start Date
March 26, 2019
End Date
December 31, 2022
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who fulfill the criteria of anterior cervical spine surgery under general anesthesia
  • Aged from 20-80 years old

Exclusion Criteria

  • 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.
  • pregnant women
  • coagulopathy

Outcomes

Primary Outcomes

upper esophageal sphincter pressure changes

Time Frame: everage 1 month in the perioperative period

upper esophageal sphincter pressure changes measured by the HRIM

Secondary Outcomes

  • hyoid bone movement(everage 1 month in the perioperative period)

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