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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-16

Study Completion Date

2020-02-15

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.

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Detailed Description

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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

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Vocal Cord Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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vocal cord ultrasonography

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

Intervention Type DEVICE

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes