Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Laryngopharyngeal Symptoms After Minimally Invasive Thyroidectomy: Comparison Between the Protector Laryngeal Mask Airway and the Endotracheal Tube.

Conditions
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Sore Throat, Dysphagia, Postoperative Pain

Intervention / Treatment
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* Device: LMA Protector
* Device: Endotracheal tube


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LMA Protector<br>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<br>* 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.<br>|
| Active Comparator: Endotracheal tube<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway management difficulty. | The efforts required to establish a secure airway and manage adequate patient ventilation will be recorded. | 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. | Within 5 minutes from induction of general anesthesia. | 
| Emergence coughing. | The incidence of cough upon emergence from general anesthesia will be recorded. | 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. | 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. | Within 20 minutes from the end of the procedure and after 1, 6, 12 and 24 hours. |