NCT03098667

Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: 424 General Military Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sore Throat
• Dysphagia
• Postoperative Pain

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-10-30
• Completion: 2017-11-01
• First posted: 2017-04-04
• Last updated: 2017-11-14

Locations

1 site across 1 country: Greece