Airway ManagementNCT05639439
Comparative Evaluation of Periglottic Airway Devices With Performed Shape
A study testing Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group A, Ventilation using the "Proseal" laryngeal mask airway and glottic view using fibrescope- Group B and Ventilation using the "I-gel" supraglottic airway device and glottic view using fibrescope- Group C in people with Airway Management, run by University Hospital of Patras at 1 site in Greece.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management
- What is being tested?
- Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group A, Ventilation using the "Proseal" laryngeal mask airway and glottic view using fibrescope- Group B and Ventilation using the "I-gel" supraglottic airway device and glottic view using fibrescope- Group C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years old, undergoing elective surgery under general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Patras
Pátrai, Ahaia, 26504
Maria Spyraki, MD, MSc, 00306944471259, maria.uop@gmail.com
Evanthia Dimitriou, MD, 00306971796704, drevadim@gmail.com
About this study
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).
Read the 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).
- Conditions
- Airway Management
- Being tested
- Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group A, Ventilation using the "Proseal" laryngeal mask airway and glottic view using fibrescope- Group B, Ventilation using the "I-gel" supraglottic airway device and glottic view using fibrescope- Group C, Ventilation using the "Protector" laryngeal airway device and glottic view using fibrescope- Group D
- Keywords
- ventilation, airway management, periglottic airway device
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group ADevice
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 BDevice
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 CDevice
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 DDevice
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 group | Role | What they receive |
|---|---|---|
| Group A- Fastrach | Active comparator | 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 Receives: Device: Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group A |
| Group B- Proseal | Active comparator | 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 Receives: Device: Ventilation using the "Proseal" laryngeal mask airway and glottic view using fibrescope- Group B |
| Group C- I-gel | Active comparator | 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 Receives: Device: Ventilation using the "I-gel" supraglottic airway device and glottic view using fibrescope- Group C |
| Group D- Protector | Active comparator | 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 Receives: Device: Ventilation using the "Protector" laryngeal airway device and glottic view using fibrescope- Group D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation sufficiency
Evaluation of ventilation sufficiency using manual bag-periglottic airway device ventilation (sufficient- moderate sufficient- insufficient)
Measured: 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
Measured: 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.
Measured: Up to study completion, an average of 2 years
Secondary outcomes (1)
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.
Measured: Up to study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Apr 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evanthia Dimitriou, University Hospital of Patras
- Investigators
- Evanthia Dimitriou, MD, Principal investigator, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639439
- Sponsor's protocol ID
- 12/03/2021anesthesia
- Status last verified
- Nov 2022
- First submitted
- 28 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Periglottic Airway Devices With Performed Shape
- ClinicalTrials.gov ID
- NCT05639439
- Acronym / sponsor ID
- 12/03/2021anesthesia
- Conditions
- Airway Management
- Keywords
- ventilation, airway management, periglottic airway device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A- Fastrach | Active comparator | Device: Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group AGroup 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 comparator | Device: Ventilation using the "Proseal" laryngeal mask airway and glottic view using fibrescope- Group BGroup 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 comparator | Device: Ventilation using the "I-gel" supraglottic airway device and glottic view using fibrescope- Group CGroup 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 comparator | Device: Ventilation using the "Protector" laryngeal airway device and glottic view using fibrescope- Group DGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥18 years old, undergoing elective surgery under general anesthesia
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group AInsertion 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) | Device | Group A- Fastrach |
| Ventilation using the "Proseal" laryngeal mask airway and glottic view using fibrescope- Group BInsertion of the laryngeal airway device "Proseal", evaluation of the ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberoptic bronchoscope) | Device | Group B- Proseal |
| Ventilation using the "I-gel" supraglottic airway device and glottic view using fibrescope- Group CInsertion 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) | Device | Group C- I-gel |
| Ventilation using the "Protector" laryngeal airway device and glottic view using fibrescope- Group DInsertion of the laryngeal airway device "Protector", evaluation of the ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberoptic bronchoscope) | Device | Group D- Protector |
Primary outcome
Ventilation sufficiency
Time frame: Up to study completion, an average of 2 years
Evaluation of ventilation sufficiency using manual bag-periglottic airway device ventilation (sufficient- moderate sufficient- insufficient)
Time required for successful periglottic airway device placement
Time frame: 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
Perfection of installation/ anatomical application to the larynx
Time frame: 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.
1 secondary outcome
Leak pressure
Time frame: Up to study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evanthia Dimitriou, MD principal investigator
University Hospital of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation using the "Fastrach" intubating laryngeal mask airway and glottic view using fibrescope - Group A, Ventilation using the "Proseal" laryngeal mask airway and glottic view using fibrescope- Group B and Ventilation using the "I-gel" supraglottic airway device and glottic view using fibrescope- Group C in people with Airway Management, run by University Hospital of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Spyraki, MD, MSc (00306944471259, maria.uop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation sufficiency (time frame: Up to study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.