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NCT05996146 Clinical Trial

Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study

Hoarseness Clinical Trial

— Hoarseness  

Official title:
Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05996146
Other study ID # HA-427
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 5, 2022
Est. completion date July 31, 2023

Study information
Verified date August 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 427
Est. completion date July 31, 2023
Est. primary completion date November 27, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary the primary outcome was to measure the incidence of hoarseness 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 voice recordings six hours after the end of anesthesia
Secondary The secondary outcome involved measuring the incidence of hoarseness 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 one month after the surgery
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