Non-neural Vocal Changes After Thyroidectomy
Assessment of Non-neural Voice Changes in Thyroidectomy Patients: A Randomized Control Trial
1 other identifier
interventional
57
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 6, 2014
CompletedFirst Posted
Study publicly available on registry
May 13, 2014
CompletedMay 13, 2014
May 1, 2014
8 months
May 6, 2014
May 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Vocal outcomes
24 hours
Laryngoscopic appearance
3 weeks
Objective vocal outcomes
3 weeks
Subjective vocal outcomes
3 weeks
Other Outcomes (1)
Pain
24 hours
Study Arms (2)
Small tube size
EXPERIMENTALSize 6.5 ETT for female, size 7.0 ETT for male
Large tube size
ACTIVE COMPARATORNormal tube size, size 7.5 for female, size 8 for male
Interventions
An endotracheal tube of size 6.5 in females and 7.0 in males was used for endotracheal intubation of patients undergoing thyroid surgery
An endotracheal tube of size 7.5 in females and 8.0 in males was used for endotracheal intubation of patients undergoing thyroid surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pre-existing vocal cord palsy or major vocal cord pathology; patients with invasive thyroid cancers; and patients undergoing concomitant lateral neck dissection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Infirmary Victoria University Hospital
Cork, Ireland
Related Publications (1)
Mehanna R, Hennessy A, Mannion S, O'Leary G, Sheahan P. Effect of Endotracheal Tube Size on Vocal Outcomes After Thyroidectomy: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Aug;141(8):690-5. doi: 10.1001/jamaoto.2015.1198.
PMID: 26158868DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rania Mehanna
South Infirmary-Victoria University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Otolaryngologist Head and neck Surgeon
Study Record Dates
First Submitted
May 6, 2014
First Posted
May 13, 2014
Study Start
October 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
May 13, 2014
Record last verified: 2014-05