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

• 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.

Study Overview

• Status: Completed
• Conditions: Vocal Cord Dysfunction
• Intervention / Treatment: Device: vocal cord ultrasonography

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Zagazig University, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Egyptian population scheduled for anterior cervical surgeries

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Alshaimaa A Kamel, M.D, Zagazig University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2019
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): February 15, 2020

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (ACTUAL): October 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Laryngeal Diseases; Vocal Cord Dysfunction
• Other Study ID Numbers: 5645

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No