Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy
12 novembre 2017 aggiornato da: Georgios Kotsovolis, 424 General Military Hospital
Study of the Laryngopharyngeal Symptoms After Minimally Invasive Thyroidectomy: Comparison Between the Protector Laryngeal Mask Airway and the Endotracheal Tube.
The patients will be allocated to 2 groups: the LMA group and the endotracheal tube (ET) group.
Airway management will be done with the LMA Protector for the patients of the LMA group and with the classic endotracheal tube for the patients of the ET group.
The main purpose of the study is to determine if the application of the LMA Protector causes less laryngopharyngeal symptoms than the endotracheal tube after minimally invasive thyroidectomy.
The secondary purpose is to confirm that the LMA Protector is a safe alternative airway management device for minimally invasive thyroidectomy.
Panoramica dello studio
Stato
Stato
Completato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
Iscrizione
79
Fase
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Thessaloniki, Grecia, 54636
- Ahepa University Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Total thyroidectomy with the minimally invasive method.
- American Society of Anesthesiologists (ASA) classification 1-3
Exclusion Criteria:
- Clinical conditions which cause any kind of airway obstruction or compromise.
- Tracheal displacement greater than 2cm from midline.
- History of gastroesophageal reflux disease.
- Expected difficult airway.
- History of impossible intubation.
- BMI>35
- Reoperation within 24hours.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
2
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: LMA Protector
After induction of general anesthesia, the LMA Protector will be applied for airway management.
The size of the laryngeal mask will be chosen according to the manufacturer's instructions.
Lubricant gel will be applied to the dorsal side of the mask to ease the insertion to the oropharynx.
The cuff of the mask will be filled with air by syringe until the indication of the integrated cuff pressure indicator is appropriate according to the manufacturer (green indication).
If the indication changes during surgery, air will be added or removed accordingly.
If the ventilation of the patient is inadequate at the beginning or anytime during the operation, the mask will be removed and the patient will be intubated
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After induction of general anesthesia, the LMA Protector will be applied for airway management.
The size of the laryngeal mask will be chosen according to the manufacturer's instructions.
Lubricant gel will be applied to the dorsal side of the mask to ease the insertion to the oropharynx.
The cuff of the mask will be filled with air by syringe until the indication of the integrated cuff pressure indicator is appropriate according to the manufacturer (green indication).
If the indication changes during surgery, air will be added or removed accordingly.
If the ventilation of the patient is inadequate at the beginning or anytime during the operation, the mask will be removed and the patient will be intubated.
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Comparatore attivo: Endotracheal tube
After induction of general anesthesia, the endotracheal tube be applied for airway management.
The size of the tube will be 7.5 for female and 8.5 for male patients.
The cuff of of the tube will be filled with 10ml air.
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After induction of general anesthesia, the endotracheal tube be applied for airway management.
The size of the tube will be 7.5 for female and 8.5 for male patients.
The cuff of of the tube will be filled with 10ml air.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Postoperative sore throat.
Lasso di tempo: Within 20 minutes from the end of the procedure.
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The patients will be asked to evaluate their postoperative constant pharyngeal pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
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Within 20 minutes from the end of the procedure.
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Postoperative sore throat.
Lasso di tempo: 1 hour after the exit from the recovery room.
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The patients will be asked to evaluate their postoperative constant pharyngeal pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
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1 hour after the exit from the recovery room.
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Postoperative sore throat.
Lasso di tempo: 6 hours after the exit from the recovery room.
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The patients will be asked to evaluate their postoperative constant pharyngeal pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
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6 hours after the exit from the recovery room.
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Postoperative sore throat.
Lasso di tempo: 12 hours after the exit from the recovery room.
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The patients will be asked to evaluate their postoperative constant pharyngeal pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
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12 hours after the exit from the recovery room.
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Postoperative sore throat.
Lasso di tempo: 24 hours after the exit from the recovery room.
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The patients will be asked to evaluate their postoperative constant pharyngeal pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
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24 hours after the exit from the recovery room.
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Postoperative surgical site pain.
Lasso di tempo: Within 20 minutes from the end of the procedure.
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The patients will be asked to evaluate their postoperative surgical trauma pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
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Within 20 minutes from the end of the procedure.
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Postoperative surgical site pain.
Lasso di tempo: 1 hour after the exit from the recovery room.
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The patients will be asked to evaluate their postoperative surgical trauma pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
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1 hour after the exit from the recovery room.
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Postoperative surgical site pain.
Lasso di tempo: 6 hours after the exit from the recovery room.
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The patients will be asked to evaluate their postoperative surgical trauma pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
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6 hours after the exit from the recovery room.
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Postoperative surgical site pain.
Lasso di tempo: 12 hours after the exit from the recovery room.
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The patients will be asked to evaluate their postoperative surgical trauma pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
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12 hours after the exit from the recovery room.
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Postoperative surgical site pain.
Lasso di tempo: 24 hours after the exit from the recovery room.
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The patients will be asked to evaluate their postoperative surgical trauma pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
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24 hours after the exit from the recovery room.
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Postoperative dysphagia.
Lasso di tempo: Within 20 minutes from the end of the procedure.
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The patients will be asked to evaluate their postoperative pharyngeal pain caused after swallowing one sip of water by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
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Within 20 minutes from the end of the procedure.
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Postoperative dysphagia.
Lasso di tempo: 1 hour after the exit from the recovery room.
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The patients will be asked to evaluate their postoperative pharyngeal pain caused after swallowing one sip of water by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
|
1 hour after the exit from the recovery room.
|
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Postoperative dysphagia.
Lasso di tempo: 6 hours after the exit from the recovery room.
|
The patients will be asked to evaluate their postoperative pharyngeal pain caused after swallowing one sip of water by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
|
6 hours after the exit from the recovery room.
|
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Postoperative dysphagia.
Lasso di tempo: 12 hours after the exit from the recovery room.
|
The patients will be asked to evaluate their postoperative pharyngeal pain caused after swallowing one sip of water by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
|
12 hours after the exit from the recovery room.
|
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Postoperative dysphagia.
Lasso di tempo: 24 hours after the exit from the recovery room.
|
The patients will be asked to evaluate their postoperative pharyngeal pain caused after swallowing one sip of water by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
|
24 hours after the exit from the recovery room.
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Airway management difficulty.
Lasso di tempo: 3 minutes after induction of general anesthesia.
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The efforts required to establish a secure airway and manage adequate patient ventilation will be recorded.
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3 minutes after induction of general anesthesia.
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Airway management complications.
Lasso di tempo: Within 5 minutes from induction of general anesthesia.
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Any complication from airway management will be recorded like bleeding from the stomatopharynx or the larynx, tooth trauma, lip trauma, etc.
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Within 5 minutes from induction of general anesthesia.
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Emergence coughing.
Lasso di tempo: Within 10 minutes from the end of the surgery.
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The incidence of cough upon emergence from general anesthesia will be recorded.
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Within 10 minutes from the end of the surgery.
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Postoperative paracetamol consumption.
Lasso di tempo: 1, 6, 12 and 24 hours after emergence from general anesthesia.
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The patients will be instructed to ask for analgesics as needed.
When rescue analgesia is required 1000mg paracetamol will be administered.
The frequency of paracetamol administration will be documented.
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1, 6, 12 and 24 hours after emergence from general anesthesia.
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Postoperative hoarseness.
Lasso di tempo: Within 20 minutes from the end of the procedure and after 1, 6, 12 and 24 hours.
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The patients postoperative hoarseness will be evaluated according to the GRBAS scale.
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Within 20 minutes from the end of the procedure and after 1, 6, 12 and 24 hours.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
- Chun BJ, Bae JS, Lee SH, Joo J, Kim ES, Sun DI. A prospective randomized controlled trial of the laryngeal mask airway versus the endotracheal intubation in the thyroid surgery: evaluation of postoperative voice, and laryngopharyngeal symptom. World J Surg. 2015 Jul;39(7):1713-20. doi: 10.1007/s00268-015-2995-7.
- Kumar C, Mishra A. Prospective randomized controlled trial on the use of flexible reinforced laryngeal mask airway (LMA) during total thyroidectomy: effects on postoperative laryngopharyngeal symptoms: reply. World J Surg. 2015 Mar;39(3):810. doi: 10.1007/s00268-014-2675-z. No abstract available.
- Moris D, Mantonakis E, Makris M, Michalinos A, Vernadakis S. Hoarseness after thyroidectomy: blame the endocrine surgeon alone? Hormones (Athens). 2014 Jan-Mar;13(1):5-15. doi: 10.1007/BF03401316.
- Ryu JH, Yom CK, Park DJ, Kim KH, Do SH, Yoo SH, Oh AY. Prospective randomized controlled trial on the use of flexible reinforced laryngeal mask airway (LMA) during total thyroidectomy: effects on postoperative laryngopharyngeal symptoms. World J Surg. 2014 Feb;38(2):378-84. doi: 10.1007/s00268-013-2269-1. Erratum In: World J Surg. 2014 Feb;38(2):519. Yom, Cha-Kyoung [corrected to Yom, Cha Kyong].
- Nemr K, Simoes-Zenari M, Cordeiro GF, Tsuji D, Ogawa AI, Ubrig MT, Menezes MH. GRBAS and Cape-V scales: high reliability and consensus when applied at different times. J Voice. 2012 Nov;26(6):812.e17-22. doi: 10.1016/j.jvoice.2012.03.005. Epub 2012 Sep 29.
- Taguchi A, Mise K, Nishikubo K, Hyodo M, Shiromoto O. Japanese version of voice handicap index for subjective evaluation of voice disorder. J Voice. 2012 Sep;26(5):668.e15-9. doi: 10.1016/j.jvoice.2011.11.005. Epub 2012 Jan 30.
- Awan SN, Helou LB, Stojadinovic A, Solomon NP. Tracking voice change after thyroidectomy: application of spectral/cepstral analyses. Clin Linguist Phon. 2011 Apr;25(4):302-20. doi: 10.3109/02699206.2010.535646. Epub 2010 Dec 15.
- Werth K, Voigt D, Dollinger M, Eysholdt U, Lohscheller J. Clinical value of acoustic voice measures: a retrospective study. Eur Arch Otorhinolaryngol. 2010 Aug;267(8):1261-71. doi: 10.1007/s00405-010-1214-2. Epub 2010 Feb 21.
- Maryn Y, De Bodt M, Roy N. The Acoustic Voice Quality Index: toward improved treatment outcomes assessment in voice disorders. J Commun Disord. 2010 May-Jun;43(3):161-74. doi: 10.1016/j.jcomdis.2009.12.004. Epub 2009 Dec 23.
- Pott L, Swick JT, Stack BC Jr. Assessment of recurrent laryngeal nerve during thyroid surgery with laryngeal mask airway. Arch Otolaryngol Head Neck Surg. 2007 Mar;133(3):266-9. doi: 10.1001/archotol.133.3.266.
- Brimacombe J, Knott J, Keller C. Laryngeal mask airway for preservation of the external branch of the superior laryngeal nerve during thyroid surgery. Can J Anaesth. 2003 Oct;50(8):858. doi: 10.1007/BF03019391. No abstract available.
- Scheuller MC, Ellison D. Laryngeal mask anesthesia with intraoperative laryngoscopy for identification of the recurrent laryngeal nerve during thyroidectomy. Laryngoscope. 2002 Sep;112(9):1594-7. doi: 10.1097/00005537-200209000-00011.
- Rosswick P. Use of the laryngeal mask airway in thyroid and parathyroid surgery as an aid in identification and preservation of the recurrent laryngeal nerves. Ann R Coll Surg Engl. 2002 Mar;84(2):148; author reply 148. No abstract available.
- Watters G. Use of the laryngeal mask airway in thyroid and parathyroid surgery as an aid in identification and preservation of the recurrent laryngeal nerves. Ann R Coll Surg Engl. 2002 Mar;84(2):148; author reply 148. No abstract available.
- Dingle AF. Use of the laryngeal mask airway in thyroid and parathyroid surgery as an aid in identification and preservation of the recurrent laryngeal nerves. Ann R Coll Surg Engl. 2002 Mar;84(2):147; author reply 148. No abstract available.
- Shah EF, Allen JG, Greatorex RA. Use of the laryngeal mask airway in thyroid and parathyroid surgery as an aid to the identification and preservation of the recurrent laryngeal nerves. Ann R Coll Surg Engl. 2001 Sep;83(5):315-8.
- Palazzo FF, Allen JG, Greatorex RA. Laryngeal mask airway and fibre-optic tracheal inspection in thyroid surgery: a method for timely identification of tracheomalacia requiring tracheostomy. Ann R Coll Surg Engl. 2000 Mar;82(2):141-2.
- Wuyts FL, De Bodt MS, Van de Heyning PH. Is the reliability of a visual analog scale higher than an ordinal scale? An experiment with the GRBAS scale for the perceptual evaluation of dysphonia. J Voice. 1999 Dec;13(4):508-17. doi: 10.1016/s0892-1997(99)80006-x.
- Rieger A, Brunne B, Striebel HW. Intracuff pressures do not predict laryngopharyngeal discomfort after use of the laryngeal mask airway. Anesthesiology. 1997 Jul;87(1):63-7. doi: 10.1097/00000542-199707000-00009.
- Rieger A, Brunne B, Hass I, Brummer G, Spies C, Striebel HW, Eyrich K. Laryngo-pharyngeal complaints following laryngeal mask airway and endotracheal intubation. J Clin Anesth. 1997 Feb;9(1):42-7. doi: 10.1016/S0952-8180(96)00209-7.
- Hobbiger HE, Allen JG, Greatorex RG, Denny NM. The laryngeal mask airway for thyroid and parathyroid surgery. Anaesthesia. 1996 Oct;51(10):972-4. doi: 10.1111/j.1365-2044.1996.tb14969.x.
- Premachandra DJ. Application of the laryngeal mask airway to thyroid surgery and the preservation of the recurrent laryngeal nerve. Ann R Coll Surg Engl. 1992 May;74(3):226. No abstract available.
- Charters P, Cave-Bigley D. Application of the laryngeal mask airway to thyroid surgery and the preservation of the recurrent laryngeal nerve. Ann R Coll Surg Engl. 1992 May;74(3):225-6. No abstract available.
- Maroof M, Siddique M, Khan RM. Post-thyroidectomy vocal cord examination by fibreoscopy aided by the laryngeal mask airway. Anaesthesia. 1992 May;47(5):445. doi: 10.1111/j.1365-2044.1992.tb02238.x. No abstract available.
- Charters P, Cave-Bigley D, Roysam CS. Should a laryngeal mask be routinely used in patients undergoing thyroid surgery? Anesthesiology. 1991 Nov;75(5):918-9. doi: 10.1097/00000542-199111000-00036. No abstract available.
- Greatorex RA, Denny NM. Application of the laryngeal mask airway to thyroid surgery and the preservation of the recurrent laryngeal nerve. Ann R Coll Surg Engl. 1991 Nov;73(6):352-4.
- Akhtar TM. Laryngeal mask airway and visualisation of vocal cords during thyroid surgery. Can J Anaesth. 1991 Jan;38(1):140. doi: 10.1007/BF03009184. No abstract available.
- Kotsovolis G, Pliakos I, Panidis S, Gkinas D, Papavramidis T. Comparison Between the Protector Laryngeal Mask Airway and the Endotracheal Tube for Minimally Invasive Thyroid and Parathyroid Surgery. World J Surg. 2019 Nov;43(11):2822-2828. doi: 10.1007/s00268-019-05122-8.
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Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
1 febbraio 2017
Completamento primario (Effettivo)
Completamento primario
30 ottobre 2017
Completamento dello studio (Effettivo)
Completamento dello studio
1 novembre 2017
Date di iscrizione allo studio
Primo inviato
Primo inviato
22 marzo 2017
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
28 marzo 2017
Primo Inserito (Effettivo)
Primo Inserito
4 aprile 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
14 novembre 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 novembre 2017
Ultimo verificato
Ultimo verificato
1 novembre 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 184/15.03.2017
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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