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

NCT04140799 | Completed

• 1 other identifier: 5645
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Vocal Cord Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Diagnostic performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound

  At 2 weeks and 3 months after the surgery

• The patient discomfort to procedure

  at the end of first 48 hour postoperative

Interventions

vocal cord ultrasonography DEVICE

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

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Egyptian population scheduled for anterior cervical surgeries

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University, Faculty of medicine

Zagazig, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32556843 DERIVED

MeSH Terms

Conditions

Vocal Cord Dysfunction

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Alshaimaa A Kamel, M.D

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Anaesthesia ,and surgical intensive care

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 28, 2019
• Study Start: January 16, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 15, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

EG (1)