Supraglottic Airway Devices PositionNCT06775184
Fiberoptic Bronchoscopy on Supraglottic Airway Devices Position
A study testing a native video image system and Fiberoptic bronchoscope in people with Supraglottic Airway Devices Position, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
A comparison of SaCo VLMTM video laryngeal mask airway with the I-gel supraglottic airway during airway management in patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Supraglottic Airway Devices Position
- What is being tested?
- a native video image system and Fiberoptic bronchoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA classification I~III, age 18~65 y/o, BMI 18~30kg/m2, elective surgery, surgery duration < 2 hours, supine position, general anesthesia with laryngeal mask airway insertion
Who cannot join
- Smoking, betel nuts use, any known anatomical variation or disease of facial or airway structure, anticipated difficult airway, limited mouth opening distance or neck motility, loosening teeth, gastroesophageal reflux history, ongoing upper airway infection or inflammation symptoms
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Fiberoptic Bronchoscopy Examination on Supraglottic Airway Devices Position in Patients Undergoing Elective Surgery
A comparison of SaCo VLMTM video laryngeal mask airway with the I-gel supraglottic airway during airway management in patients undergoing elective surgery.
Read the detailed description
The position of the supraglottic airway is checked using a fiberoptic endoscope: The bronchoscope is placed at the opening of the laryngeal mask, and assessed using the following grading system: Grade 1: Vocal cords not visible. Grade 2: Vocal cords and anterior epiglottis visible. Grade 3: Vocal cords and posterior epiglottis visible. Grade 4: Only vocal cords visible.
- Conditions
- Supraglottic Airway Devices Position
- Being tested
- a native video image system, Fiberoptic bronchoscope
- Keywords
- supraglottic device, video laryngeal mask, fiberoptic bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a native video image systemDevice
The visualization of the glottic structures through the SaCoVLM™ imaging system is graded as follows: Grade1: Visibility of the lateral portion of the right epiglottic fold and part of the laryngeal inlet. Grade 2: Visibility of both epiglottic folds and part of the laryngeal inlet. Grade 3: Visibility of the laryngeal inlet and part of the vocal cords. Grade 4: Visibility of the entire vocal cords.
Fiberoptic bronchoscopeDevice
The position of the i-Gel is checked using a fiberoptic endoscope
| Study group | Role | What they receive |
|---|---|---|
| Third-generation SADs (SaCoVLM) | Experimental | The third-generation SADs (i.e. SaCoVLM™) combines video system and laryngeal mask with gastric drain. Receives: Device: a native video image system |
| Second-generation SADs (I-gel™) | Active comparator | The second-generation SADs (i.e. I-gel™) with a gastric drain conduit have designed to reduce the risk of gastric reflux and aspiration. Receives: Device: a native video image system; Device: Fiberoptic bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
glottic visualization grades by fiberoptic exam assessment
Grade 1: vocal cords were not visualizedGrade 2: vocal cords and anterior epiglottis were visualizedGrade 3: vocal cords and posterior epiglottis were visualized Grade 4: vocal cords only were visualized
Measured: From anesthesia induction to the end of surgery
Secondary outcomes (1)
Intra-operative effectiveness
Secondary outcomes were evaluated by oropharyngeal sealing pressure, first attempt success rate, insertion time
Measured: From anesthesia induction to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraglottic Airway Devices PositionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KMUHIRB-F(I)-20240331, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775184
- Sponsor's protocol ID
- KMUHIRB-F(I)-20240331
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: not decided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fiberoptic Bronchoscopy Examination on Supraglottic Airway Devices Position in Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT06775184
- Acronym / sponsor ID
- KMUHIRB-F(I)-20240331
- Conditions
- Supraglottic Airway Devices Position
- Keywords
- supraglottic device, video laryngeal mask, fiberoptic bronchoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jan 2025 (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.
A comparison of SaCo VLMTM video laryngeal mask airway with the I-gel supraglottic airway during airway management in patients undergoing elective surgery.
Detailed description
The position of the supraglottic airway is checked using a fiberoptic endoscope: The bronchoscope is placed at the opening of the laryngeal mask, and assessed using the following grading system: Grade 1: Vocal cords not visible. Grade 2: Vocal cords and anterior epiglottis visible. Grade 3: Vocal cords and posterior epiglottis visible. Grade 4: Only vocal cords visible.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Third-generation SADs (SaCoVLM) | Experimental | Device: a native video image systemThe third-generation SADs (i.e. SaCoVLM™) combines video system and laryngeal mask with gastric drain. |
| Second-generation SADs (I-gel™) | Active comparator | Device: a native video image system, Device: Fiberoptic bronchoscopeThe second-generation SADs (i.e. I-gel™) with a gastric drain conduit have designed to reduce the risk of gastric reflux and aspiration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA classification I~III, age 18~65 y/o, BMI 18~30kg/m2, elective surgery, surgery duration < 2 hours, supine position, general anesthesia with laryngeal mask airway insertion
Key exclusion criteria (1 listed)
- Smoking, betel nuts use, any known anatomical variation or disease of facial or airway structure, anticipated difficult airway, limited mouth opening distance or neck motility, loosening teeth, gastroesophageal reflux history, ongoing upper airway infection or inflammation symptoms
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 |
|---|---|---|
| a native video image systemThe visualization of the glottic structures through the SaCoVLM™ imaging system is graded as follows: Grade1: Visibility of the lateral portion of the right epiglottic fold and part of the laryngeal inlet. Grade 2: Visibility of both epiglottic folds and part of the laryngeal inlet. Grade 3: Visibility of the laryngeal inlet and part of the vocal cords. Grade 4: Visibility of the entire vocal cords. | Device | Second-generation SADs (I-gel™), Third-generation SADs (SaCoVLM) |
| Fiberoptic bronchoscopeThe position of the i-Gel is checked using a fiberoptic endoscope | Device | Second-generation SADs (I-gel™) |
Primary outcome
glottic visualization grades by fiberoptic exam assessment
Time frame: From anesthesia induction to the end of surgery
Grade 1: vocal cords were not visualizedGrade 2: vocal cords and anterior epiglottis were visualizedGrade 3: vocal cords and posterior epiglottis were visualized Grade 4: vocal cords only were visualized
1 secondary outcome
Intra-operative effectiveness
Time frame: From anesthesia induction to the end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: Undecided. not decided
Related trials for Supraglottic Airway Devices Position
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New-Generation GMA Laryngeal Mask Airway Versus Conventional Inflatable Laryngeal Mask Airway
Supraglottic Airway Devices Position
Recruiting
The Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
Airway Management Assessment, Supraglottic Airways
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.
Questions about this trial
What is this clinical trial studying?
A study testing a native video image system and Fiberoptic bronchoscope in people with Supraglottic Airway Devices Position, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 1 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: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ICHENG LU (886-975356677, u9251112@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glottic visualization grades by fiberoptic exam assessment (time frame: From anesthesia induction to the end of surgery). 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 15 Jan 2025.