Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

The optimum size of endotracheal tube (ETT) for general anaesthesia remains a matter of debate. Choice of ETT size may be of particular pertinence during thyroid surgery, for a number or reasons. Because of the strong attachments of the thyroid gland to the trachea, intraoperative mobilization of the thyroid will lead to inevitable movement of the trachea and larynx against the fixed ETT, with consequent risk of traumatic injury to tracheal mucosa, vocal cords, and arytenoids. Thus thyroidectomy is likely to be associated with a greater risk of laryngeal trauma related to the ETT than operations outside the Head and Neck region where there is no movement of the larynx. On top of this, postoperative vocal impairment comprises one of the most important concerns after thyroidectomy, usually attributed to impaired vocal fold function secondary to recurrent laryngeal nerve injury. However, post-thyroidectomy vocal impairment can also occur in cases where the recurrent laryngeal nerve is preserved. Thus, concerns regarding vocal outcomes after thyroidectomy tend to be foremost in the mind of both the surgeon and the patient, and any measures which can be taken to minimize post-thyroidectomy hoarseness, which might include choosing the optimal ETT size, would appear to constitute a worthwhile endeavor.

Laryngeal trauma due to endotracheal intubation is probably more common than appreciated, however, given that symptoms of sore throat and hoarseness after most operations are generally self-limiting, this is not usually a major cause of concern. On the other hand, postoperative vocal symptoms may be a major cause of anxiety after thyroidectomy, due to fear of damage to the recurrent laryngeal nerve or the external branch of the superior laryngeal nerve (SLN). Laryngeal trauma without impairment of vocal fold function has been reported to be a significant cause of vocal symptoms after thyroid surgery. However, no previously published study has attempted to correlate post-thyroidectomy vocal symptoms or signs of laryngeal trauma with ETT size.

The hypothesis of the present study was that intubation with a smaller size ETT would lead to less trauma to the larynx during thyroidectomy than intubation with a standard size tube, and this would be reflected through less postoperative throat symptoms and objective laryngeal alterations. The rationale for this hypothesis was that a smaller caliber tube would be less unyielding when the larynx is moved against it, and thus would lead to less laryngeal injury. In order to address this question, the investigators designed a randomized controlled trial, comparing the impact of intubation with a smaller size tube (size 6.5 for females, and size 7 for males) with that of intubation with ETTs of the standard size used in the investigators department (size 7.5 for females, and size 8 for males). ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02136459
Study type Interventional
Source South Infirmary-Victoria University Hospital
Contact
Status Completed
Phase N/A
Start date October 2012
Completion date June 2013

See also
  Status Clinical Trial Phase
Completed NCT02855866 - Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy N/A
Completed NCT05043584 - Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions N/A
Completed NCT05044351 - Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial N/A
Completed NCT04082845 - Effect of Web-Based Training With Thyroidectomy Patients N/A
Completed NCT04186715 - Near Infrared Spectroscopy in Thyroidectomy
Not yet recruiting NCT02949856 - E-T Tube Cuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck N/A
Withdrawn NCT03060499 - Post Thyroidectomy Myocardial Function
Completed NCT03108742 - Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy N/A
Completed NCT03035383 - Purse String Suture for the Closure of Large Thyroidectomy Resulted in Better Cosmetics N/A
Recruiting NCT06002984 - Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in Thyroid Surgery N/A
Recruiting NCT06162390 - Optimal Concentration of Remifentanil for NIM Tube Intubation With Low-dose NMBA N/A
Recruiting NCT04481893 - Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy N/A
Completed NCT02577068 - Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy N/A
Completed NCT03349294 - Clinical Study of Biokinetic Model of Iodine-131 in Total(Near) Thyroidectomy Patients.
Recruiting NCT05851560 - Prospective Comparison of the Effect on Antiadhesive Barriers During Thyroid or Parathyroid Surgery Phase 1
Completed NCT02768753 - Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy N/A
Recruiting NCT05642741 - Validation of a Hypoparathyroidism Self-questionnaire
Withdrawn NCT02568085 - Trial Evaluating Use of Arista in Total Thyroidectomy N/A
Recruiting NCT01607242 - Impact of Total Thyroidectomy on Voice and Swallowing N/A
Completed NCT05681338 - Effect of the Coughing Technique During Subcutaneous Heparin Injection N/A