Comparative Evaluation of Periglottic Airway Devices With Performed Shape

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-04-30

Brief Summary

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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).

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Detailed Description

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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

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Airway Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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)

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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)

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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)

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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)

Interventions

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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)

Intervention Type 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)

Intervention Type 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)

Intervention Type 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)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No