Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy

Not Applicable

Completed

• Conditions: Sore Throat; Dysphagia; Postoperative Pain
• Interventions: Device: LMA Protector; Device: Endotracheal tube

• Registration Number: NCT03098667
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Primary Completion: 2017-10-30
• Status Verified: 2017-11
• Study Completion: 2017-11-01
• Last Update Submitted: 2017-11-12
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMA Protector	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
Endotracheal tube	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

Name	Time	Method
Postoperative sore throat.	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.	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.	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

Name	Time	Method
Airway management difficulty.	3 minutes after induction of general anesthesia.	The efforts required to establish a secure airway and manage adequate patient ventilation will be recorded.
Airway management complications.	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.
Postoperative paracetamol consumption.	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.
Emergence coughing.	Within 10 minutes from the end of the surgery.	The incidence of cough upon emergence from general anesthesia will be recorded.
Postoperative hoarseness.	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.

Trial Locations

Locations (1)

AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece