Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy
12 november 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
79
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Thessaloniki, Grekland, 54636
- Ahepa University Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative sore throat.
Tidsram: 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).
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Within 20 minutes from the end of the procedure.
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Postoperative sore throat.
Tidsram: 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).
|
1 hour after the exit from the recovery room.
|
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Postoperative sore throat.
Tidsram: 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).
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6 hours after the exit from the recovery room.
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Postoperative sore throat.
Tidsram: 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).
|
12 hours after the exit from the recovery room.
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Postoperative sore throat.
Tidsram: 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).
|
24 hours after the exit from the recovery room.
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Postoperative surgical site pain.
Tidsram: 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.
Tidsram: 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).
|
1 hour after the exit from the recovery room.
|
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Postoperative surgical site pain.
Tidsram: 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).
|
6 hours after the exit from the recovery room.
|
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Postoperative surgical site pain.
Tidsram: 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).
|
12 hours after the exit from the recovery room.
|
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Postoperative surgical site pain.
Tidsram: 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).
|
24 hours after the exit from the recovery room.
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Postoperative dysphagia.
Tidsram: 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.
Tidsram: 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).
|
1 hour after the exit from the recovery room.
|
|
Postoperative dysphagia.
Tidsram: 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.
|
|
Postoperative dysphagia.
Tidsram: 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.
|
|
Postoperative dysphagia.
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Airway management difficulty.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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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Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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].
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2017
Primärt slutförande (Faktisk)
30 oktober 2017
Avslutad studie (Faktisk)
1 november 2017
Studieregistreringsdatum
Först inskickad
22 mars 2017
Först inskickad som uppfyllde QC-kriterierna
28 mars 2017
Första postat (Faktisk)
4 april 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 november 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 november 2017
Senast verifierad
1 november 2017
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Andra studie-ID-nummer
- 184/15.03.2017
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