Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy

424 General Military Hospital

Status: Completed

Conditions: Postoperative Pain; Dysphagia; Sore Throat

Treatments: Device: Endotracheal tube; Device: LMA Protector

Study type: Interventional

Funder types: Other

Identifiers

NCT03098667

184/15.03.2017

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 2 patient groups

LMA Protector

Experimental group

Description:

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

Treatment:

Device: LMA Protector

Endotracheal tube

Active Comparator group

Description:

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.

Treatment:

Device: Endotracheal tube