Multicenter Study of the Protector Laryngeal Mask

Completed

• Conditions: Airway

• Registration Number: NCT03272776
• Lead Sponsor: Matilde Zaballos

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-09-01
• Study First Posted: 2017-09-06
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the number of attempts to insert of the LMA Protector	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 Outcome Measures

Name	Time	Method
Blood pressure during insertion of LMA protect	Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector	Blood pressure in mmHg
Heart rate during insertion of LMA protect	Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector	heart rate in beep per minute
Oropharyngeal leak pressure of the LMA Protector	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)
BIS data	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)

Trial Locations

Locations (1)

Servicio de Anestesia, Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain