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NCT Number: NCT04140799

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

• 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.

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Key information

Conditions

Vocal Cord Dysfunction Laryngeal Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Tract Diseases

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zagazig University, Faculty of medicine

Zagazig, Egypt

About this study

  • Design: A prospective cohort study.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vocal cord ultrasonography

Device

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

Primary outcomes

  1. Predictive performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound: conventional middle approach compared to lateral approach

    Time frame: at the end of the first 48 hours after the surgery

    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

Secondary outcomes

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

    Time frame: At 2 weeks and 3 months after the surgery

    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

  2. The patient discomfort to procedure

    Time frame: at the end of first 48 hour postoperative

    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."

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries: A Prospective Cohort Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 28, 2019
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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