Comparative Evaluation of Periglottic Airway Devices With Performed Shape

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).

Study Overview

• Status: Recruiting
• Conditions: Airway Management
• Intervention / Treatment: Device: Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group A; Device: Ventilation using the "Proseal" laryngeal mask airway and glottic view using fibrescope- Group B; Device: Ventilation using the "I-gel" supraglottic airway device and glottic view using fibrescope- Group C; Device: Ventilation using the "Protector" laryngeal airway device and glottic view using fibrescope- Group D

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Spyraki, MD, MSc; Phone Number: 00306944471259; Email: maria.uop@gmail.com
• Study Contact Backup: Name: Evanthia Dimitriou, MD; Phone Number: 00306971796704; Email: drevadim@gmail.com

Study Locations

• Greece
  • Ahaia
    • Patras, Ahaia, Greece, 26504
      • Recruiting
      • University Hospital of Patras
      • Contact: Maria Spyraki, MD, MSc; Phone Number: 00306944471259; Email: maria.uop@gmail.com
      • Contact: Evanthia Dimitriou, MD; Phone Number: 00306971796704; Email: drevadim@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital of Patras
• Investigators: Principal Investigator: Evanthia Dimitriou, MD, University Hospital of Patras

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: ventilation; airway management; periglottic airway device
• Other Study ID Numbers: 12/03/2021anesthesia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No