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Completed

NCT Number: NCT02136459

Non-neural Vocal Changes After Thyroidectomy

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Infirmary Victoria University Hospital

Cork, Ireland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Small Tube size

Other

An endotracheal tube of size 6.5 in females and 7.0 in males was used for endotracheal intubation of patients undergoing thyroid surgery

Other names: Smaller size of endotracheal tube (ETT) inserted

Large Tube size

Other

An endotracheal tube of size 7.5 in females and 8.0 in males was used for endotracheal intubation of patients undergoing thyroid surgery

Other names: Standard size endotracheal tube

Primary outcomes

  1. Laryngoscopic appearance

    Time frame: 24 hours

    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

Secondary outcomes

  1. Vocal outcomes

    Time frame: 24 hours

    Grade, roughness, breathiness, aesthenia and strain (GRBAS) score

  2. Laryngoscopic appearance

    Time frame: 3 weeks

    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. Objective vocal outcomes

    Time frame: 3 weeks

    Grade, roughness, breathiness, aesthenia and strain (GRBAS) score

  4. Subjective vocal outcomes

    Time frame: 3 weeks

    VHI (Voice Handicap Index) scores

Other outcomes

  1. Pain

    Time frame: 24 hours

    VAS score

Sponsors and collaborators

Lead sponsor

South Infirmary-Victoria University Hospital

Other

Registry information

Official study title

Assessment of Non-neural Voice Changes in Thyroidectomy Patients: A Randomized Control Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 13, 2014
Registry last updated
May 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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