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

• Conditions: Pharyngeal Pressure Change
• Interventions: Procedure: anterior approach; Procedure: posterior appraoch

• Registration Number: NCT04123522
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-06
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-11
• Last Update Posted: 2019-10-11
• Study Start: 2019-11-02
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Patients who fulfill the criteria of cervical spine surgery under general anesthesia 2. Aged from 20-80 years old -

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
anterior cervical spine surgery	anterior approach	The patients will be enrolled for elective anterior cervical spine surgery.
posterior cervical spine surgery	posterior appraoch	The patients will be enrolled for elective postieor cervical spine surgery

Primary Outcome Measures

Name	Time	Method
mean pharyngeal peak pressure	preoperative, postoperative day 1 and 7	the pharyngeal presssure change during swallowing