Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03098667
• Date of registration: 22/03/2017
• Prospective Registration: No
• Primary sponsor: 424 General Military Hospital
• Public title: Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy
• Scientific title: Study of the Laryngopharyngeal Symptoms After Minimally Invasive Thyroidectomy: Comparison Between the Protector Laryngeal Mask Airway and the Endotracheal Tube.
• Date of first enrolment: February 1, 2017
• Target sample size: 79
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03098667
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Greece

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sore Throat

Dysphagia

Postoperative Pain

Intervention(s)

Device: Endotracheal tube

Device: LMA Protector

Primary Outcome(s)

Postoperative sore throat. [Time Frame: 6 hours after the exit from the recovery room.]

Postoperative sore throat. [Time Frame: Within 20 minutes from the end of the procedure.]

Postoperative dysphagia. [Time Frame: 12 hours after the exit from the recovery room.]

Postoperative dysphagia. [Time Frame: 6 hours after the exit from the recovery room.]

Postoperative sore throat. [Time Frame: 24 hours after the exit from the recovery room.]

Postoperative surgical site pain. [Time Frame: 12 hours after the exit from the recovery room.]

Postoperative surgical site pain. [Time Frame: 1 hour after the exit from the recovery room.]

Postoperative surgical site pain. [Time Frame: 24 hours after the exit from the recovery room.]

Postoperative sore throat. [Time Frame: 1 hour after the exit from the recovery room.]

Postoperative surgical site pain. [Time Frame: 6 hours after the exit from the recovery room.]

Postoperative surgical site pain. [Time Frame: Within 20 minutes from the end of the procedure.]

Postoperative sore throat. [Time Frame: 12 hours after the exit from the recovery room.]

Postoperative dysphagia. [Time Frame: 1 hour after the exit from the recovery room.]

Postoperative dysphagia. [Time Frame: 24 hours after the exit from the recovery room.]

Postoperative dysphagia. [Time Frame: Within 20 minutes from the end of the procedure.]

Secondary Outcome(s)

Postoperative hoarseness. [Time Frame: Within 20 minutes from the end of the procedure and after 1, 6, 12 and 24 hours.]

Airway management difficulty. [Time Frame: 3 minutes after induction of general anesthesia.]

Airway management complications. [Time Frame: Within 5 minutes from induction of general anesthesia.]

Emergence coughing. [Time Frame: Within 10 minutes from the end of the surgery.]

Postoperative paracetamol consumption. [Time Frame: 1, 6, 12 and 24 hours after emergence from general anesthesia.]

Secondary ID(s)

184/15.03.2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors