Skip to main content
OpenTrials
Completed

NCT Number: NCT03272776

Multicenter Study of the Protector Laryngeal Mask

The study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Protector Laryngeal Mask, a new second generation disposable supraglottic airway device, in patients undergoing elective surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Servicio de Anestesia, Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

About this study

Laryngeal masks (LM) and supraglottic devices (SGD), in all their different forms, have become an authentic innovation in airway management especially in day surgery.

LMA Protector (Teleflex Medical, Athlone, Ireland) is a new disposable SGD currently available for anaesthetic practice. It is made of silicone (with no latex in its composition) and shares some of the characteristics of the second generation SGDs (as the presence of a gastric access channel); however, it has an additional drainage channel, both channels terminate distally in a camera behind the mask cuff. The presence of two drainage channels ("male" and "female") increases the patient safety against regurgitation, both of distal gastric content and secretions located in the oropharyngeal region. The gastric access channel called "female" also allows the insertion of a nasogastric tube if required. These drainage channels are useful for diagnosing the correct position of the mask, since the observation of leaks or gas through it can help diagnose a displacement the mask.

LMA Protector is designed with a preformed anatomic curve, and the airway conduct has an elliptical cross section, which ends distally in the mask. This design follows the anatomy of the human airway, which facilitates the insertion of the device. The softness of the mask material allows easy insertion.

Doubts regarding the transmission of infectious diseases with reusable devices makes disposable devices such as LMA Protector, one of the most interesting devices for use in anaesthetic procedures that are usually performed with SGD.

Its characteristics in the design, composition by a smooth and atraumatic material, the presence of two gastric drainage accesses, with potential improved patient safety and its characteristic of being disposable suggests a significant expansion of its use in the coming years .

In contrast to other SGDs that have been evaluated extensively, to date there are no large clinical studies showing its suitably and performance in a daily clinical scenario.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Surgery procedures usually performed with supraglottic devices.
  • ASA physical status I-III patients
  • Age 18-75
  • Signed inform consent

Exclusion criteria

  • Patients with known difficult airway
  • Patients with predicted difficult airway
  • Patients with increased risk of aspiration
  • Patient refusal to participate in the study.

Treatment and study plan

Protector Laryngeal Mask airway

Device

Evaluate the time of insertion, performance, security and insertion success rate of the Protector Laryngeal Mask in patients under general anasthesia.

Primary outcomes

  1. Evaluate the number of attempts to insert of the LMA Protector

    Time frame: The number of insertion attempts will be collected after anesthesia induction: 1 minute after the administration of propofol

    Insertion attempts: from picking up the LMA Protector until the mask is placed into the patient mouth . (in numbers)

Secondary outcomes

  1. Blood pressure during insertion of LMA protect

    Time frame: Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector

    Blood pressure in mmHg

  2. Heart rate during insertion of LMA protect

    Time frame: Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector

    heart rate in beep per minute

  3. BIS data

    Time frame: Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector (To evaluate the evolution of BIS values during insertion of the LMA

    number from 100 (awake) to 40-45 (anesthetic status)

  4. Oropharyngeal leak pressure of the LMA Protector

    Time frame: The Oropharyngeal leak pressure of the LMA Protector will be collected 5 minutes after the LMA Protector will be inserted

    The Oropharyngeal leak pressure of the LMA Protector will be determined with an intracuff pressure of 60 cm H2O by closing the expiratory valve of the breathing circle circuit at a fixed gas flow of 3 L/min and noting the pressure at which an oropharyngeal leak occurs. (in cm H2O)

Sponsors and collaborators

Lead sponsor

Matilde Zaballos

Other

Collaborators

  • Teleflex

Registry information

Official study title

A Multicenter Study of the Protector Laryngeal Mask in Non Paralyzed, Anesthetized Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2017
Registry last updated
Feb 21, 2019

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.

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