Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy

NCT03098667 | Completed DMC

• 1 other identifier: 184/15.03.2017
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sore Throat; Dysphagia; Postoperative Pain

Outcome Measures

Primary Outcomes (15)

• Postoperative sore throat.

  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).

  Within 20 minutes from the end of the procedure.

• Postoperative sore throat.

  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).

  1 hour after the exit from the recovery room.

• Postoperative sore throat.

  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).

  6 hours after the exit from the recovery room.

• Postoperative sore throat.

  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).

  12 hours after the exit from the recovery room.

• Postoperative sore throat.

  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).

  24 hours after the exit from the recovery room.

• Postoperative surgical site pain.

  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).

  Within 20 minutes from the end of the procedure.

• Postoperative surgical site pain.

  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).

  1 hour after the exit from the recovery room.

• Postoperative surgical site pain.

  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).

  6 hours after the exit from the recovery room.

• Postoperative surgical site pain.

  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).

  12 hours after the exit from the recovery room.

• Postoperative surgical site pain.

  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).

  24 hours after the exit from the recovery room.

• Postoperative dysphagia.

  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).

  Within 20 minutes from the end of the procedure.

• Postoperative dysphagia.

  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.

• Postoperative dysphagia.

  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.

• Postoperative dysphagia.

  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.

• Postoperative dysphagia.

  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.

Secondary Outcomes (5)

• Airway management difficulty.

  3 minutes after induction of general anesthesia.

• Airway management complications.

  Within 5 minutes from induction of general anesthesia.

• Emergence coughing.

  Within 10 minutes from the end of the surgery.

• Postoperative paracetamol consumption.

  1, 6, 12 and 24 hours after emergence from general anesthesia.

• Postoperative hoarseness.

  Within 20 minutes from the end of the procedure and after 1, 6, 12 and 24 hours.

Study Arms (2)

LMA Protector

EXPERIMENTAL

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

Device: LMA Protector

Endotracheal tube

ACTIVE COMPARATOR

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.

Device: Endotracheal tube

Interventions

LMA Protector DEVICE

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.

LMA Protector

Endotracheal tube DEVICE

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.

Endotracheal tube

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total thyroidectomy with the minimally invasive method.
• American Society of Anesthesiologists (ASA) classification 1-3

You may not qualify if:

• 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.

Sponsors & Collaborators

• 424 General Military Hospital: lead

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

Related Publications (29)

• 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.

  PMID: 25670039 BACKGROUND

• 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.

  PMID: 24981369 BACKGROUND

• 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.

  PMID: 24722123 BACKGROUND

• 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.

  PMID: 24146195 BACKGROUND

• 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.

  PMID: 23026732 BACKGROUND

• 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.

  PMID: 22285453 BACKGROUND

• 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.

  PMID: 21158501 BACKGROUND

• 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.

  PMID: 20567980 BACKGROUND

• 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.

  PMID: 20080243 BACKGROUND

• 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.

  PMID: 17372084 BACKGROUND

• 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.

  PMID: 16928254 BACKGROUND

• 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.

  PMID: 14525838 BACKGROUND

• 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.

  PMID: 12352669 BACKGROUND

• 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.

  PMID: 11995766 BACKGROUND

• 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.

  PMID: 11995765 BACKGROUND

• 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.

  PMID: 11995764 BACKGROUND

• 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.

  PMID: 11806554 BACKGROUND

• 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.

  PMID: 10743437 BACKGROUND

• 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.

  PMID: 10622517 BACKGROUND

• 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.

  PMID: 9232135 BACKGROUND

• 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.

  PMID: 9051545 BACKGROUND

• 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.

  PMID: 8984876 BACKGROUND

• 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.

  PMID: 1616271 BACKGROUND

• 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.

  PMID: 1616270 BACKGROUND

• 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.

  PMID: 1599080 BACKGROUND

• 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.

  PMID: 1952223 BACKGROUND

• 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.

  PMID: 1759763 BACKGROUND

• 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.

  PMID: 1989734 BACKGROUND

• 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.

  PMID: 31410514 DERIVED

MeSH Terms

Conditions

Pharyngitis; Deglutition Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Georgios Kotsovolis

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 4, 2017
• Study Start: February 1, 2017
• Primary Completion: October 30, 2017
• Study Completion: November 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)