Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05996146

Acronym

Hoarseness

Enrollment

427

Registered

2023-08-16

Start date

2022-05-05

Completion date

2023-07-31

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hoarseness

Keywords

hoarseness, spine surgery

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
the primary outcome was to measure the incidence of hoarseness	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

Measure	Time frame	Description
The secondary outcome involved measuring the incidence of hoarseness one month after the surgery	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

Countries

South Korea

Outcome results