Skip to main content
OpenTrials
Completed

NCT Number: NCT03098667

Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sore Throat Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Infections Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Postoperative Complications Postoperative Pain Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AHEPA University Hospital

Thessaloniki, 54636, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LMA Protector

Device

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.

Endotracheal tube

Device

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

424 General Military Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2017
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.