Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy
12 november 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
79
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Thessaloniki, Griekenland, 54636
- Ahepa University Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Postoperative sore throat.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 6 hours 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).
|
6 hours after the exit from the recovery room.
|
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Postoperative dysphagia.
Tijdsspanne: 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.
Tijdsspanne: 24 hours 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).
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24 hours after the exit from the recovery room.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Airway management difficulty.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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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Medewerkers en onderzoekers
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Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 februari 2017
Primaire voltooiing (Werkelijk)
30 oktober 2017
Studie voltooiing (Werkelijk)
1 november 2017
Studieregistratiedata
Eerst ingediend
22 maart 2017
Eerst ingediend dat voldeed aan de QC-criteria
28 maart 2017
Eerst geplaatst (Werkelijk)
4 april 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
14 november 2017
Laatste update ingediend die voldeed aan QC-criteria
12 november 2017
Laatst geverifieerd
1 november 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 184/15.03.2017
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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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