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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04123522
Enrollment
24
Registered
2019-10-11
Start date
2019-11-02
Completion date
2022-12-31
Last updated
2019-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharyngeal Pressure Change

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.

Interventions

anterior approach

PROCEDUREposterior appraoch

posteiror appraoch

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
mean pharyngeal peak pressurepreoperative, postoperative day 1 and 7the pharyngeal presssure change during swallowing

Contacts

Primary ContactChih-Jun Lai, MD
littlecherrytw@gmail.com23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026