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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04140799
• Other study ID #: 5645
• Status: Completed
• Start date: January 16, 2019
• Est. completion date: February 15, 2020

Study information

• Verified date: June 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 15, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vocal Cord Dysfunction

Intervention

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

Locations

Country	Name	City	State
Egypt	Zagazig University, Faculty of medicine	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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