Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy

November 12, 2017 updated by: Georgios Kotsovolis, 424 General Military Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54636
        • Ahepa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative sore throat.
Time Frame: Within 20 minutes from the end of the procedure.
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).
Within 20 minutes from the end of the procedure.
Postoperative sore throat.
Time Frame: 1 hour 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).
1 hour after the exit from the recovery room.
Postoperative sore throat.
Time Frame: 6 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).
6 hours after the exit from the recovery room.
Postoperative sore throat.
Time Frame: 12 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).
12 hours after the exit from the recovery room.
Postoperative sore throat.
Time Frame: 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).
24 hours after the exit from the recovery room.
Postoperative surgical site pain.
Time Frame: Within 20 minutes from the end of the procedure.
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).
Within 20 minutes from the end of the procedure.
Postoperative surgical site pain.
Time Frame: 1 hour 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).
1 hour after the exit from the recovery room.
Postoperative surgical site pain.
Time Frame: 6 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).
6 hours after the exit from the recovery room.
Postoperative surgical site pain.
Time Frame: 12 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).
12 hours after the exit from the recovery room.
Postoperative surgical site pain.
Time Frame: 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).
24 hours after the exit from the recovery room.
Postoperative dysphagia.
Time Frame: Within 20 minutes from the end of the procedure.
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).
Within 20 minutes from the end of the procedure.
Postoperative dysphagia.
Time Frame: 1 hour 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).
1 hour after the exit from the recovery room.
Postoperative dysphagia.
Time Frame: 6 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).
6 hours after the exit from the recovery room.
Postoperative dysphagia.
Time Frame: 12 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).
12 hours after the exit from the recovery room.
Postoperative dysphagia.
Time Frame: 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).
24 hours after the exit from the recovery room.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway management difficulty.
Time Frame: 3 minutes after induction of general anesthesia.
The efforts required to establish a secure airway and manage adequate patient ventilation will be recorded.
3 minutes after induction of general anesthesia.
Airway management complications.
Time Frame: 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.
Within 5 minutes from induction of general anesthesia.
Emergence coughing.
Time Frame: Within 10 minutes from the end of the surgery.
The incidence of cough upon emergence from general anesthesia will be recorded.
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.
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.
1, 6, 12 and 24 hours after emergence from general anesthesia.
Postoperative hoarseness.
Time Frame: 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.
Within 20 minutes from the end of the procedure and after 1, 6, 12 and 24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

424 General Military Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

October 30, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 12, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 184/15.03.2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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