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- Essai clinique NCT02136459
Non-neural Vocal Changes After Thyroidectomy
Assessment of Non-neural Voice Changes in Thyroidectomy Patients: A Randomized Control Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Cork, Irlande
- South Infirmary Victoria University Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Small tube size
Size 6.5 ETT for female, size 7.0 ETT for male
|
An endotracheal tube of size 6.5 in females and 7.0 in males was used for endotracheal intubation of patients undergoing thyroid surgery
Autres noms:
|
|
Comparateur actif: Large tube size
Normal tube size, size 7.5 for female, size 8 for male
|
An endotracheal tube of size 7.5 in females and 8.0 in males was used for endotracheal intubation of patients undergoing thyroid surgery
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Laryngoscopic appearance
Délai: 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
|
24 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Vocal outcomes
Délai: 24 hours
|
Grade, roughness, breathiness, aesthenia and strain (GRBAS) score
|
24 hours
|
|
Laryngoscopic appearance
Délai: 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 weeks
|
|
Objective vocal outcomes
Délai: 3 weeks
|
Grade, roughness, breathiness, aesthenia and strain (GRBAS) score
|
3 weeks
|
|
Subjective vocal outcomes
Délai: 3 weeks
|
VHI (Voice Handicap Index) scores
|
3 weeks
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain
Délai: 24 hours
|
VAS score
|
24 hours
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Rania Mehanna, South Infirmary-Victoria University Hospital
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- SIVUH1
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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