Comparative Evaluation of Periglottic Airway Devices With Performed Shape
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group A- Fastrach 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
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)
|
| Active Comparator: Group B- Proseal 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
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)
|
| Active Comparator: Group C- I-gel 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
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)
|
| Active Comparator: Group D- Protector 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
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)
|
Outcome Measures
Primary Outcome Measures
- Ventilation sufficiency [Up to study completion, an average of 2 years]
Evaluation of ventilation sufficiency using manual bag-periglottic airway device ventilation (sufficient- moderate sufficient- insufficient)
- Time required for successful periglottic airway device placement [Up to study completion, an average of 2 years]
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
- Perfection of installation/ anatomical application to the larynx [Up to study completion, an average of 2 years]
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.
Secondary Outcome Measures
- Leak pressure [Up to study completion, an average of 2 years]
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.
Eligibility Criteria
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
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Obstetric population
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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)
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Patients with anticipated difficult airway, planned for awake intubation
-
Patients' refusal to participate in the trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Patras | Patras | Ahaia | Greece | 26504 |
Sponsors and Collaborators
- University Hospital of Patras
Investigators
- Principal Investigator: Evanthia Dimitriou, MD, University Hospital of Patras
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12/03/2021anesthesia