Comparative Evaluation of Periglottic Airway Devices With Performed Shape

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05639439

Enrollment

160

Registered

2022-12-06

Start date

2021-04-01

Completion date

2024-04-30

Last updated

2022-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management

Keywords

ventilation, airway management, periglottic airway device

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).

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).

Interventions

DEVICEVentilation 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)

DEVICEVentilation 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)

DEVICEVentilation 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)

DEVICEVentilation 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Time required for successful periglottic airway device placement	Up to study completion, an average of 2 years	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
Ventilation sufficiency	Up to study completion, an average of 2 years	Evaluation of ventilation sufficiency using manual bag-periglottic airway device ventilation (sufficient- moderate sufficient- insufficient)
Perfection of installation/ anatomical application to the larynx	Up to study completion, an average of 2 years	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.

Secondary

Measure	Time frame	Description
Leak pressure	Up to study completion, an average of 2 years	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.

Countries

Greece

Contacts

Primary ContactMaria Spyraki, MD, MSc

maria.uop@gmail.com00306944471259

Backup ContactEvanthia Dimitriou, MD

drevadim@gmail.com00306971796704

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026