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

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National Taiwan University

Status

Unknown

Conditions

Pharyngeal Pressure Change

Treatments

Procedure: anterior approach
Procedure: posterior appraoch

Study type

Observational

Funder types

Other

Identifiers

NCT04123522
201907079RINA

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria:

    1. Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
  1. Patients who have the risk of difficult ventilation or intubation. 3. pregnant women 4. coagulopathy

Trial design

24 participants in 2 patient groups

anterior cervical spine surgery
Description:
The patients will be enrolled for elective anterior cervical spine surgery.
Treatment:
Procedure: anterior approach
posterior cervical spine surgery
Description:
The patients will be enrolled for elective postieor cervical spine surgery
Treatment:
Procedure: posterior appraoch

Trial contacts and locations

0

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Central trial contact

Chih-Jun Lai, MD

Data sourced from clinicaltrials.gov

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