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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04140799
Enrollment
90
Registered
2019-10-28
Start date
2019-01-16
Completion date
2020-02-15
Last updated
2020-06-30

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

Conditions

Vocal Cord Dysfunction

Brief 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.

Interventions

DEVICEvocal cord ultrasonography

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

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Predictive performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound: conventional middle approach compared to lateral approachat the end of the first 48 hours after the surgeryThe 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

Secondary

MeasureTime frameDescription
Diagnostic performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasoundAt 2 weeks and 3 months after the surgeryThe 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
The patient discomfort to procedureat the end of first 48 hour postoperativeThe 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.

Countries

Egypt

Outcome results

None listed

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