Airway
Conditions
Keywords
LMA Protector, Second Generation Laryngeal Masks, Airway, Dual Gastric Acces, Teleflex, Supraglottic Devices, Ambulatory Surgery
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.
Interventions
DEVICEProtector Laryngeal Mask airway
Evaluate the time of insertion, performance, security and insertion success rate of the Protector Laryngeal Mask in patients under general anasthesia.
Sponsors
Teleflex
Matilde Zaballos
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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) |
Countries
Spain
Outcome results
None listed