Comparative Evaluation of Periglottic Airway Devices With Performed Shape

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate four, most popular periglottic airway devices as regards to ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberscope).

Detailed Description
-----------------
After being informed about the study and potential risks, all patients (>18 years old scheduled for elective surgery under general anesthesia) giving written informed consent will undergo preoperative screening examination to determine eligibility for study entry. A randomization process has been previously done, according to which the participants have been classified into one of the four groups of the study. Each study group is scheduled to receive one of the four periglottic devices (LM FastrachTM, LM ProsealTM, LM I-GelTM, LM ProtectorTM) while evaluating the ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberscope).

Official Title
-----------------
Comparative Evaluation of Periglottic Airway Devices With Performed Shape

Conditions
-----------------
Airway Management

Intervention / Treatment
-----------------
* Device: Ventilation using the Fastrach intubating laryngeal mask airway and glottic view using fibrescope - Group A
* Device: Ventilation using the Proseal laryngeal mask airway and glottic view using fibrescope- Group B
* Device: Ventilation using the I-gel supraglottic airway device and glottic view using fibrescope- Group C
* Device: Ventilation using the Protector laryngeal airway device and glottic view using fibrescope- Group D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 years old, undergoing elective surgery under general anesthesia Exclusion Criteria: Patients < 18 years old Patients undergoing emergency surgery or trauma patients Obstetric population Patients receiving regional anesthesia Patients to whom the use of periglottic airway device is contraindicated Patients with RODS score ≥ 1 (score to predict difficult laryngeal mask placement 1-4) Patients with anticipated difficult airway, planned for awake intubation Patients' refusal to participate in the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A- Fastrach<br>Group of 40 patients scheduled for elective surgery under general anesthesia are planned to be ventilated through the intubating laryngeal mask airway Fastrach, while the laryngeal view through Fastrach will be evaluated using a flexible fiberoptic bronchoscope | Device: Ventilation using the Fastrach intubating laryngeal mask airway and glottic view using fibrescope - Group A<br>* Insertion of the intubating laryngeal airway device Fastrach, evaluation of the ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberoptic bronchoscope)<br>|
| Active Comparator: Group B- Proseal<br>Group of 40 patients scheduled for elective surgery under general anesthesia are planned to be ventilated through the Proseal laryngeal mask airway, while the laryngeal view through Proseal will be evaluated using a flexible fiberoptic bronchoscope | Device: Ventilation using the Proseal laryngeal mask airway and glottic view using fibrescope- Group B<br>* Insertion of the laryngeal airway device Proseal, evaluation of the ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberoptic bronchoscope)<br>|
| Active Comparator: Group C- I-gel<br>Group of 40 patients scheduled for elective surgery under general anesthesia are planned to be ventilated using the I-gel supraglottic airway device, while the laryngeal view through I-gel will be evaluated using a flexible fiberoptic bronchoscope | Device: Ventilation using the I-gel supraglottic airway device and glottic view using fibrescope- Group C<br>* Insertion of the supraglottic airway device I-gel, evaluation of the ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberoptic bronchoscope)<br>|
| Active Comparator: Group D- Protector<br>Group of 40 patients scheduled for elective surgery under general anesthesia are planned to be ventilated using the Protector laryngeal mask airway, while the laryngeal view through Protector will be evaluated using a flexible fiberoptic bronchoscope | Device: Ventilation using the Protector laryngeal airway device and glottic view using fibrescope- Group D<br>* Insertion of the laryngeal airway device Protector, evaluation of the ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberoptic bronchoscope)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilation sufficiency | Evaluation of ventilation sufficiency using manual bag-periglottic airway device ventilation (sufficient- moderate sufficient- insufficient) | Up to study completion, an average of 2 years | 
| Time required for successful periglottic airway device placement | Time required from the beginning of the insertion of the periglottic airway device until the appearance of the first capnographic waveform with end-tidal CO2> 20mmHg | Up to study completion, an average of 2 years | 
| Perfection of installation/ anatomical application to the larynx | After sufficient placement of the periglottic devise, a fibrescope is inserted through the mask in order to evaluate the glottic view (grade I-IV) and the anatomical application of the mask to the larynx. | Up to study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leak pressure | The leak pressure of each mask will be measured applying fresh gas flow (FGF) of 3L/min while keeping the adjustable pressure- limiting (APL) valve closed. | Up to study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ventilation, airway management, periglottic airway device