Thyroidectomy Clinical Trial
Official title:
Assessment of Non-neural Voice Changes in Thyroidectomy Patients: A Randomized Control Trial
The purpose of this study is to test the investigators hypothesis that intubation with a smaller ETT would lead to reduced postoperative vocal impairment and laryngoscopic evidence of laryngeal trauma than intubation with a standard size ETT.
Status | Completed |
Enrollment | 57 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients aged 18 years and over scheduled to undergo thyroid surgery performed by one of two surgeons for benign or malignant thyroid disease during the study Exclusion Criteria: - pre-existing vocal cord palsy or major vocal cord pathology; patients with invasive thyroid cancers; and patients undergoing concomitant lateral neck dissection |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Ireland | South Infirmary Victoria University Hospital | Cork |
Lead Sponsor | Collaborator |
---|---|
South Infirmary-Victoria University Hospital |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain | VAS score | 24 hours | No |
Primary | Laryngoscopic appearance | A laryngoscopic score of 0,1,2 was given according to absence (0), presence (1) or presence of severe (2) findings of each the following laryngoscopic findings: erythema, oedema, polyp or nodule, and reduced vocal mobility | 24 hours | No |
Secondary | Vocal outcomes | Grade, roughness, breathiness, aesthenia and strain (GRBAS) score | 24 hours | No |
Secondary | Laryngoscopic appearance | A laryngoscopic score of 0,1,2 was given according to absence (0), presence (1) or presence of severe (2) findings of each the following laryngoscopic findings: erythema, oedema, polyp or nodule, and reduced vocal mobility | 3 weeks | No |
Secondary | Objective vocal outcomes | Grade, roughness, breathiness, aesthenia and strain (GRBAS) score | 3 weeks | No |
Secondary | Subjective vocal outcomes | VHI (Voice Handicap Index) scores | 3 weeks | No |
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