NCT04140799

Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries

Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries: A Prospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

• Anterior cervical discectomy and fusion (ACDF) is a highly effective and safe method for spinal cord and cervical root decompression. Vocal cord paralysis secondary to recurrent laryngeal nerve injury is a common complication after ACDF. The incidence reported as high as 22%. The standard technique for vocal cord evaluation and the most commonly used tool is direct laryngoscopy. Laryngoscopy causes patients annoyance and could potentially contribute to poor patient compliance. Ultrasonography is a non-invasive technique that is used as an alternative tool.

Detailed description

1. Design: A prospective cohort study. 2. Sample size: Assuming that the target population is 240 and positive predictive value of transcutaneous laryngeal ultrasonography is 89.4%. So, the sample size is 91 cases using OPEN Source Epidemiologic Statistics for Public Health (OPENEPI) with confidence interval 95% and power of test is 80%. All patients underwent transcutaneous laryngeal ultrasonography examination by both anterior and lateral approach of the Vocal Cords (VCs) before the surgery, immediately after extubation, 2 h, 12h, 24 and 48hour postoperatively by an anesthesiologist with an experience of at least three years in ultrasonography scan.

Conditions

• Vocal Cord Dysfunction

Interventions

Type	Name	Description
DEVICE	vocal cord ultrasonography	assess vocal cord motion and recurrent nerve function by Transcutaneous laryngeal Ultrasonography in patients scheduled for anterior cervical spine surgeries

Timeline

• Start date: 2019-01-16
• Primary completion: 2020-02-01
• Completion: 2020-02-15
• First posted: 2019-10-28
• Last updated: 2020-06-30

Locations

1 site across 1 country: Egypt