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

Using the High Resolution Impedance Manometry to Evaluate Swallowing Function After Cervical Spine Surgery: Anterior vs Posterior Approach

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.

Study Overview

• Status: Unknown
• Conditions: Pharyngeal Pressure Change
• Intervention / Treatment: Procedure: anterior approach; Procedure: posterior appraoch

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 Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

• Study Contact: Name: Chih-Jun Lai, MD; Phone Number: 23123456; Email: littlecherrytw@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients recieved elective cervical spine surgery

Description

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.

2. Patients who have the risk of difficult ventilation or intubation. 3. pregnant women 4. coagulopathy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
anterior cervical spine surgery; The patients will be enrolled for elective anterior cervical spine surgery.	Procedure: anterior approach; anterior approach; Other Names: anterior appraoch
posterior cervical spine surgery; The patients will be enrolled for elective postieor cervical spine surgery	Procedure: posterior appraoch; posteiror appraoch; Other Names: posterior approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean pharyngeal peak pressure	the pharyngeal presssure change during swallowing	preoperative, postoperative day 1 and 7

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 2, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 6, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 201907079RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No