Comparative Evaluation of Periglottic Airway Devices With Performed Shape

University Hospital of Patras

Status: Enrolling

Conditions: Airway Management

Treatments: Device: Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group A; Device: Ventilation using the "I-gel" supraglottic airway device and glottic view using fibrescope- Group C; Device: Ventilation using the "Proseal" laryngeal mask airway and glottic view using fibrescope- Group B; Device: Ventilation using the "Protector" laryngeal airway device and glottic view using fibrescope- Group D

Study type: Interventional

Funder types: Other

Identifiers

NCT05639439

12/03/2021anesthesia

Details and patient eligibility

About

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).

Full 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).

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

Group A- Fastrach

Active Comparator group

Description:

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

Treatment:

Device: Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group A

Group B- Proseal

Active Comparator group

Description:

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

Treatment:

Device: Ventilation using the "Proseal" laryngeal mask airway and glottic view using fibrescope- Group B

Group C- I-gel

Active Comparator group

Description:

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

Treatment:

Device: Ventilation using the "I-gel" supraglottic airway device and glottic view using fibrescope- Group C

Group D- Protector

Active Comparator group

Description:

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

Treatment:

Device: Ventilation using the "Protector" laryngeal airway device and glottic view using fibrescope- Group D