Using the High Resolution Impedance Manometry to Evaluate Swallowing Function After Cervical Spine Surgery

NCT ID: NCT04123522

Last Updated: 2019-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-02
• Study Completion Date: 2022-12-31

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

anterior cervical spine surgery

The patients will be enrolled for elective anterior cervical spine surgery.

anterior approach

Intervention Type: PROCEDURE

anterior approach

posterior cervical spine surgery

The patients will be enrolled for elective postieor cervical spine surgery

posterior appraoch

Intervention Type: PROCEDURE

posteiror appraoch

Interventions

anterior approach

anterior approach

Intervention Type: PROCEDURE

posterior appraoch

posteiror appraoch

Intervention Type: PROCEDURE

Other Intervention Names

anterior appraoch; posterior approach

Eligibility Criteria

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Chih-Jun Lai, MD

Role: CONTACT

littlecherrytw@gmail.com

23123456

Other Identifiers

201907079RINA

Identifier Type: -

Identifier Source: org_study_id