An interventional study of Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group A and Ventilation using the "Proseal" laryngeal mask airway and glottic view using fibrescope- Group B in Airway Management, sponsored by University Hospital of Patras. Status unknown at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-06.
Sponsored by University Hospital of Patras · Not applicable, Interventional, and Supportive care
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).
University Hospital of Patras is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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
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
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
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 intubating laryngeal airway device "Fastrach", evaluation of the ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberoptic bronchoscope)
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)
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)
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)
Ventilation sufficiency
Evaluation of ventilation sufficiency using manual bag-periglottic airway device ventilation (sufficient- moderate sufficient- insufficient)
Time frame: 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
Time frame: 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.
Time frame: Up to study completion, an average of 2 years
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.
Time frame: Up to study completion, an average of 2 years
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University Hospital of Patras