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

Study Overview
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Brief Summary
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• 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
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Design: A prospective cohort study. 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.

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

Conditions
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Vocal Cord Dysfunction

Intervention / Treatment
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* Device: vocal cord ultrasonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient acceptance. Both sex Age (21-60) years old. American Society of Anesthesiologist I / II Elective anterior cervical spine surgeries patient With Body Mass index (25-35 kg/m²) Exclusion Criteria: Patient refusal. Altered mental status. Patients with per-existing neurological or thyroid disease affecting vocal cord function. Patients with a diagnosis of primary untreated laryngeal/hypopharyngeal cancer. Patient with a history of thyroidectomy affecting recurrent laryngeal nerve. Patient with a history of laryngeal trauma. Pre-operative voice abnormalities.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: vocal cord ultrasonography|assess vocal cord motion and recurrent nerve function by Transcutaneous laryngeal Ultrasonography in patients scheduled for anterior cervical spine surgeries|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound: conventional middle approach compared to lateral approach | The predictive performance of postoperative vocal cord edema and paralysis using the conventional middle and lateral approach of trans cutaneous laryngeal ultrasound will be evaluated using sensitivity, specificity and accuracy . the gold standard for diagnosis of vocal cord edema and paralysis will be the rigid laryngoscopy | at the end of the first 48 hours after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound | The diagnostic performance of postoperative vocal cord paralysis using the trans cutaneous laryngeal ultrasound for diagnosis of recovery of vocal cord paralysis , among subject with vocal cord paralysis | At 2 weeks and 3 months after the surgery | 
| The patient discomfort to procedure | The patient discomfort to sonography and rigid laryngoscopy by Discomfort score(Visual analogue scale (VAS)) regarding the amount of discomfort experienced during the procedure. Discomfort was reported by placing a mark on a 10-cm line, with the ends representing not at all uncomfortable and extremely uncomfortable. | at the end of first 48 hour postoperative |