Non-neural Vocal Changes After Thyroidectomy
Assessment of Non-neural Voice Changes in Thyroidectomy Patients: A Randomized Control Trial
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Cork、アイルランド
- South Infirmary Victoria University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Small tube size
Size 6.5 ETT for female, size 7.0 ETT for male
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An endotracheal tube of size 6.5 in females and 7.0 in males was used for endotracheal intubation of patients undergoing thyroid surgery
他の名前:
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アクティブコンパレータ:Large tube size
Normal tube size, size 7.5 for female, size 8 for male
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An endotracheal tube of size 7.5 in females and 8.0 in males was used for endotracheal intubation of patients undergoing thyroid surgery
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Laryngoscopic appearance
時間枠:24 hours
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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
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24 hours
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Vocal outcomes
時間枠:24 hours
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Grade, roughness, breathiness, aesthenia and strain (GRBAS) score
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24 hours
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Laryngoscopic appearance
時間枠:3 weeks
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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
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3 weeks
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Objective vocal outcomes
時間枠:3 weeks
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Grade, roughness, breathiness, aesthenia and strain (GRBAS) score
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3 weeks
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Subjective vocal outcomes
時間枠:3 weeks
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VHI (Voice Handicap Index) scores
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3 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain
時間枠:24 hours
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VAS score
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24 hours
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協力者と研究者
捜査官
- 主任研究者:Rania Mehanna、South Infirmary-Victoria University Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SIVUH1
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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