Comparative Evaluation of Periglottic Airway Devices With Performed Shape
1 other identifier
interventional
160
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 28, 2022
CompletedFirst Posted
Study publicly available on registry
December 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedDecember 6, 2022
November 1, 2022
2.1 years
November 28, 2022
November 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Leak pressure
Up to study completion, an average of 2 years
Study Arms (4)
Group A- Fastrach
ACTIVE COMPARATORGroup 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
Group B- Proseal
ACTIVE COMPARATORGroup 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
Group C- I-gel
ACTIVE COMPARATORGroup 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
Group D- Protector
ACTIVE COMPARATORGroup 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
Interventions
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)
Eligibility Criteria
You may qualify if:
- Patients ≥18 years old, undergoing elective surgery under general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Patras
Pátrai, Ahaia, 26504, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evanthia Dimitriou, MD
University Hospital of Patras
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist, MD
Study Record Dates
First Submitted
November 28, 2022
First Posted
December 6, 2022
Study Start
April 1, 2021
Primary Completion
April 30, 2023
Study Completion
April 30, 2024
Last Updated
December 6, 2022
Record last verified: 2022-11