Clinical trial NCT03098667: Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy
Official title: Study of the Laryngopharyngeal Symptoms After Minimally Invasive Thyroidectomy: Comparison Between the Protector Laryngeal Mask Airway and the Endotracheal Tube.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sore Throat
Dysphagia
Postoperative Pain
Lead sponsor: 424 General Military Hospital
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Postoperative sore throat.
timeFrame: Within 20 minutes from the end of the procedure.
measure: Postoperative sore throat.
timeFrame: 1 hour after the exit from the recovery room.
measure: Postoperative sore throat.
timeFrame: 6 hours after the exit from the recovery room.
measure: Postoperative sore throat.
timeFrame: 12 hours after the exit from the recovery room.
measure: Postoperative sore throat.
timeFrame: 24 hours after the exit from the recovery room.
measure: Postoperative surgical site pain.
timeFrame: Within 20 minutes from the end of the procedure.
measure: Postoperative surgical site pain.
timeFrame: 1 hour after the exit from the recovery room.
measure: Postoperative surgical site pain.
timeFrame: 6 hours after the exit from the recovery room.
measure: Postoperative surgical site pain.
timeFrame: 12 hours after the exit from the recovery room.
measure: Postoperative surgical site pain.
timeFrame: 24 hours after the exit from the recovery room.
measure: Postoperative dysphagia.
timeFrame: Within 20 minutes from the end of the procedure.
measure: Postoperative dysphagia.
timeFrame: 1 hour after the exit from the recovery room.
measure: Postoperative dysphagia.
timeFrame: 6 hours after the exit from the recovery room.
measure: Postoperative dysphagia.
timeFrame: 12 hours after the exit from the recovery room.
measure: Postoperative dysphagia.
timeFrame: 24 hours after the exit from the recovery room.
Secondary outcomes:
measure: Airway management difficulty.
timeFrame: 3 minutes after induction of general anesthesia.
measure: Airway management complications.
timeFrame: Within 5 minutes from induction of general anesthesia.
measure: Emergence coughing.
timeFrame: Within 10 minutes from the end of the surgery.
measure: Postoperative paracetamol consumption.
timeFrame: 1, 6, 12 and 24 hours after emergence from general anesthesia.
measure: Postoperative hoarseness.
timeFrame: Within 20 minutes from the end of the procedure and after 1, 6, 12 and 24 hours.
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital
Study officials:
References:
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