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Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098667
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Georgios Kotsovolis, 424 General Military Hospital

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.

Condition or disease Intervention/treatment Phase
Sore Throat Dysphagia Postoperative Pain Device: LMA Protector Device: Endotracheal tube Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Study of the Laryngopharyngeal Symptoms After Minimally Invasive Thyroidectomy: Comparison Between the Protector Laryngeal Mask Airway and the Endotracheal Tube.
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : November 1, 2017

Arm Intervention/treatment
Experimental: 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
Device: 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.

Active Comparator: 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.
Device: 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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).


Secondary Outcome Measures :
  1. Airway management difficulty. [ Time Frame: 3 minutes after induction of general anesthesia. ]
    The efforts required to establish a secure airway and manage adequate patient ventilation will be recorded.

  2. Airway management complications. [ Time Frame: Within 5 minutes from induction of general anesthesia. ]
    Any complication from airway management will be recorded like bleeding from the stomatopharynx or the larynx, tooth trauma, lip trauma, etc.

  3. Emergence coughing. [ Time Frame: Within 10 minutes from the end of the surgery. ]
    The incidence of cough upon emergence from general anesthesia will be recorded.

  4. Postoperative paracetamol consumption. [ Time Frame: 1, 6, 12 and 24 hours after emergence from general anesthesia. ]
    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.

  5. Postoperative hoarseness. [ Time Frame: Within 20 minutes from the end of the procedure and after 1, 6, 12 and 24 hours. ]
    The patients postoperative hoarseness will be evaluated according to the GRBAS scale.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098667


Locations
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Greece
AHEPA University Hospital
Thessaloniki, Greece, 54636
Sponsors and Collaborators
424 General Military Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Georgios Kotsovolis, Dr Georgios Kotsovolis, 424 General Military Hospital
ClinicalTrials.gov Identifier: NCT03098667    
Other Study ID Numbers: 184/15.03.2017
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases