NCT05639439

Comparative Evaluation of Periglottic Airway Devices With Performed Shape

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University Hospital of Patras · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Airway Management

Interventions

Type	Name	Description
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)
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)
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)
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)

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-04-30
• Completion: 2024-04-30
• First posted: 2022-12-06
• Last updated: 2022-12-06

Locations

1 site across 1 country: Greece