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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A- Fastrach | Active Comparator | 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 |
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| Group B- Proseal | Active Comparator | 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 |
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| Group C- I-gel | Active Comparator | 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 |
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| Group D- Protector | Active Comparator | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group A | Device | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Spyraki, MD, MSc | Contact | 00306944471259 | maria.uop@gmail.com | |
| Evanthia Dimitriou, MD | Contact | 00306971796704 | drevadim@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Evanthia Dimitriou, MD | University Hospital of Patras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Patras | Recruiting | Pátrai | Ahaia | 26504 | Greece |
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| Ventilation using the "Proseal" laryngeal mask airway and glottic view using fibrescope- Group B | Device | 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) |
|
| Ventilation using the "I-gel" supraglottic airway device and glottic view using fibrescope- Group C | Device | 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) |
|
| Ventilation using the "Protector" laryngeal airway device and glottic view using fibrescope- Group D | Device | 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) |
|
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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