Clinical trial NCT03891940: Swallowing Motor Function After Cervical Spine Surgery With Anterior Approach
Official title: Evaluation of Changes of Swallowing Motor Function After Cervical Spine Surgery With Anterior Approach- the Implication of High Resolution Impedance Manometry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Receiving Anterior Cervical Spine Surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who fulfill the criteria of anterior cervical spine surgery under general anesthesia

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: upper esophageal sphincter pressure changes
timeFrame: everage 1 month in the perioperative period
Secondary outcomes:
measure: hyoid bone movement
timeFrame: everage 1 month in the perioperative period
Other outcomes:
Locations:
Study officials:
References:
citation: Lai CJ, Cheng YJ, Lai DM, Wu CY, Chang WT, Tsuang FY. Applying High-Resolution Impedance Manometry for Detecting Swallowing Change in Anterior Cervical Spine Surgery Patients. Front Surg. 2022 Mar 16;9:851126. doi: 10.3389/fsurg.2022.851126. eCollection 2022.