Clinical trial NCT04140799: Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries
Official title: Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vocal Cord Dysfunction
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-10-28
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian population scheduled for anterior cervical surgeries

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Predictive performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound: conventional middle approach compared to lateral approach
timeFrame: at the end of the first 48 hours after the surgery
Secondary outcomes:
measure: Diagnostic performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound
timeFrame: At 2 weeks and 3 months after the surgery
measure: The patient discomfort to procedure
timeFrame: at the end of first 48 hour postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University, Faculty of medicine
Study officials:
affiliation: Zagazig University
name: Alshaimaa A Kamel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kamel AAF, Amin OAI, Hassan MAMM, Elmesallamy WAEA, Hassan EM. Ultrasound prediction for vocal cord dysfunction in patients scheduled for anterior cervical spine surgeries: a prospective cohort study. J Clin Monit Comput. 2021 Aug;35(4):869-875. doi: 10.1007/s10877-020-00546-3. Epub 2020 Jun 15.