Sore ThroatNCT03098667
Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy
A study testing LMA Protector and Endotracheal tube in people with Sore Throat and Dysphagia, run by 424 General Military Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sore Throat, Dysphagia, Postoperative Pain
- What is being tested?
- LMA Protector and Endotracheal tube
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2017to 1 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total thyroidectomy with the minimally invasive method.
- American Society of Anesthesiologists (ASA) classification 1-3
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sore Throat, Dysphagia, Postoperative Pain
- Being tested
- LMA Protector, Endotracheal tube
- Medical subject headings
- Pharyngitis, Deglutition Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA ProtectorDevice
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.
Endotracheal tubeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 24 hours after the exit from the recovery room.
Secondary outcomes (5)
Airway management difficulty.
The efforts required to establish a secure airway and manage adequate patient ventilation will be recorded.
Measured: 3 minutes after induction of general anesthesia.
Airway management complications.
Any complication from airway management will be recorded like bleeding from the stomatopharynx or the larynx, tooth trauma, lip trauma, etc.
Measured: Within 5 minutes from induction of general anesthesia.
Emergence coughing.
The incidence of cough upon emergence from general anesthesia will be recorded.
Measured: Within 10 minutes from the end of the surgery.
Postoperative paracetamol consumption.
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.
Measured: 1, 6, 12 and 24 hours after emergence from general anesthesia.
Postoperative hoarseness.
The patients postoperative hoarseness will be evaluated according to the GRBAS scale.
Measured: Within 20 minutes from the end of the procedure and after 1, 6, 12 and 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Feb 2017
- Primary completion30 Oct 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- 424 General Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Kotsovolis, 424 General Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098667
- Sponsor's protocol ID
- 184/15.03.2017
- Status last verified
- Nov 2017
- First submitted
- 22 Mar 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25670039Kumar 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.
PubMed 24981369Moris 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.
PubMed 24722123Ryu 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.
PubMed 24146195Nemr 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.
PubMed 23026732Taguchi 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.
PubMed 22285453Awan 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.
PubMed 21158501Werth 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.
PubMed 20567980Maryn 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.
PubMed 20080243Pott 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.
PubMed 17372084Vakil 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.
PubMed 16928254Brimacombe 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.
PubMed 14525838Scheuller 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.
PubMed 12352669Rosswick 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.
PubMed 11995766Watters 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.
PubMed 11995765
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Laryngopharyngeal Symptoms After Minimally Invasive Thyroidectomy: Comparison Between the Protector Laryngeal Mask Airway and the Endotracheal Tube.
- ClinicalTrials.gov ID
- NCT03098667
- Acronym / sponsor ID
- 184/15.03.2017
- Conditions
- Sore Throat, Dysphagia, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- 424 General Military HospitalUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA Protector | Experimental | Device: LMA ProtectorAfter 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 |
| Endotracheal tube | Active comparator | Device: Endotracheal tubeAfter 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Total thyroidectomy with the minimally invasive method.
- American Society of Anesthesiologists (ASA) classification 1-3
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMA ProtectorAfter 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 tubeAfter 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 |
Primary outcome
Postoperative sore throat.
Time frame: Within 20 minutes from the end of the procedure.
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).
Postoperative sore throat.
Time frame: 1 hour after the exit from the recovery room.
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).
Postoperative sore throat.
Time frame: 6 hours after the exit from the recovery room.
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).
Postoperative sore throat.
Time frame: 12 hours after the exit from the recovery room.
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).
Postoperative sore throat.
Time frame: 24 hours after the exit from the recovery room.
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).
Postoperative surgical site pain.
Time frame: Within 20 minutes from the end of the procedure.
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).
Postoperative surgical site pain.
Time frame: 1 hour after the exit from the recovery room.
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).
Postoperative surgical site pain.
Time frame: 6 hours after the exit from the recovery room.
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).
Postoperative surgical site pain.
Time frame: 12 hours after the exit from the recovery room.
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).
Postoperative surgical site pain.
Time frame: 24 hours after the exit from the recovery room.
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).
Postoperative dysphagia.
Time frame: Within 20 minutes from the end of the procedure.
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).
Postoperative dysphagia.
Time frame: 1 hour 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).
Postoperative dysphagia.
Time frame: 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).
Postoperative dysphagia.
Time frame: 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).
Postoperative dysphagia.
Time frame: 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).
5 secondary outcomes
Airway management difficulty.
Time frame: 3 minutes after induction of general anesthesia.
Airway management complications.
Time frame: Within 5 minutes from induction of general anesthesia.
Emergence coughing.
Time frame: Within 10 minutes from the end of the surgery.
Postoperative paracetamol consumption.
Time frame: 1, 6, 12 and 24 hours after emergence from general anesthesia.
Postoperative hoarseness.
Time frame: Within 20 minutes from the end of the procedure and after 1, 6, 12 and 24 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Background: PubMed 25670039Chun 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.
- Background: PubMed 24981369Kumar 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.
- Background: PubMed 24722123Moris 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.
- Background: PubMed 24146195Ryu 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.
- Background: PubMed 23026732Nemr 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.
- Background: PubMed 22285453Taguchi 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.
- Background: PubMed 21158501Awan 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.
- Background: PubMed 20567980Werth 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.
- Background: PubMed 20080243Maryn 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.
- Background: PubMed 17372084Pott 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.
- Background: PubMed 16928254Vakil 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.
- Background: PubMed 14525838Brimacombe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA Protector and Endotracheal tube in people with Sore Throat and Dysphagia, run by 424 General Military Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative sore throat. (time frame: Within 20 minutes from the end of the procedure.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03098667, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.