Swallowing Motor Function After Cervical Spine Surgery With Anterior Approach

Patients Receiving Anterior Cervical Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03891940
• Other study ID #: 201901089RINC
• Status: Not yet recruiting
• Start date: March 26, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2019
• Source: National Taiwan University Hospital
• Contact: Fon-Yih Tsuang, MD
• Phone: +886972651124
• Email: tsuangfy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1. Patients who fulfill the criteria of anterior 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

Related Conditions & MeSH terms

• Patients Receiving Anterior Cervical Spine Surgery

Intervention

Procedure:
• patients recieving anterior cervical spine surgery
Anterior cervical discectomy with fusion, or ACDF, is a surgery designed to relieve spinal cord or nerve root pressure in the neck by removing all or part of a damaged disc

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	upper esophageal sphincter pressure changes	upper esophageal sphincter pressure changes measured by the HRIM	everage 1 month in the perioperative period
Secondary	hyoid bone movement	the distance of hyoid bone movement measured by the ultrasonography	everage 1 month in the perioperative period