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Completed

NCT Number: NCT05996146

Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study

Early diagnosis and appropriate treatment of hoarseness is known to improve quality of life and treatment outcomes. Therefore, appropriate research on the incidence of hoarseness after surgery is necessary. In this study, investigator aim to investigate incidence of hoarseness after spine surgery and the correlation between the Voice Handicap Index (VHI)-10, used as a criterion, and acoustic parameters, while also validating the efficacy of our research methods.

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Key information

Conditions

Hoarseness Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Voice Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

The primary outcome of this study is the incidence of hoarseness on the day of surgery.

The secondary outcomes include the incidence of hoarseness at one month after surgery, as well as examining the correlation between acoustic parameters, risk factors, and the occurrence of hoarseness.

Investigator conducted a comparative analysis of risk factor for hoarseness in patients with different VHI-10 scores on the day of surgery and 30 days after surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age range is 20 to 80 years old
  • degenerative spine conditions
  • visit at Seoul National University Hospital only
  • Patients who voluntarily consent to participate in the study

Exclusion criteria

  • History of surgery around the airway or mediastinum
  • patients with vocal cord-related disorders
  • Patients with fractures, bleeding, or other trauma
  • Patients with neuromuscular diseases, Parkinson's disease, or psychiatric disorders
  • Patients who cannot be extubated or who are transferred to the ICU after surgery
  • Pregnant women
  • Patients who do not wish to participate in the study

Treatment and study plan

Primary outcomes

  1. the primary outcome was to measure the incidence of hoarseness

    Time frame: voice recordings six hours after the end of anesthesia

    the primary outcome was to measure the incidence of voice disorders by conducting Voice Handicap Index-10 (minimum score 0 to maximum score 46, lower score is better) scoring and voice recordings six hours after the end of anesthesia

Secondary outcomes

  1. The secondary outcome involved measuring the incidence of hoarseness one month after the surgery

    Time frame: one month after the surgery

    analyzed the correlation between Voice Handicap Index-10 (minimum score 0 to maximum score 46, lower score is better) scores and voice acoustic parameter analysis

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Acronym: Hoarseness

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 16, 2023
Registry last updated
Aug 21, 2023

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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