Vocal Cord Dysfunction Clinical Trial
Official title:
Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries: A Prospective Cohort Study
• 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.
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.
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