Comparative Evaluation of Periglottic Airway Devices With Performed Shape

Airway Management Clinical Trial

Official title:

Comparative Evaluation of Periglottic Airway Devices With Performed Shape

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05639439
• Other study ID #: 12/03/2021anesthesia
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2022
• Source: University Hospital of Patras
• Contact: Maria Spyraki, MD, MSc
• Phone: 00306944471259
• Email: maria.uop[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Management

Intervention

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)
• 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)
• 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)
• 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)

Locations

Country	Name	City	State
Greece	University Hospital of Patras	Patras	Ahaia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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