Supraglottic Airways for General AnesthesiaNCT07726472
Study of Accuracy of Placement and Performance Test in Detecting Supraglottic Airway Placement Compared to Fiberoptic View. Recruited Patients in University Malaya Medical Center, Malaysia, Undergoing General Anesthesia With Supraglottic Airway.
An observational study of Supraglottic Airways for General Anesthesia, run by University of Malaya at 1 site in Malaysia.
Trial summary
The goal of this cross sectional observational study is to compare the accuracy of placement and performance tests to gold standard method of fiberscope assisted insertion of Supraglottic Airway(SGA) Device for optimal SGA placement, in ASA 1-3 adult patients undergoing general anesthesia in University Malaya Medical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Supraglottic Airways for General Anesthesia
- What is being tested?
- fiberoptic view of glottis
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 14 Aug 2025to 28 Nov 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing general anesthesia with supraglottic ariway(SGA) in University Malaya Medical Center(UMMC)
Who may be able to join
- American Society of Anesthesiology(ASA) class 1-3.
Who cannot join
- Patients with limited mouth opening.
- Patients with pharyngeal or laryngeal abnormalities that affect SGA placement.
- Patients with high risk of aspiration (gastroparesis, inadequate fasting time, hiatal hernia)
- Patients with reduced lung or chest compliance or increase airway resistance (ARDS, asthma)
- Patients with lower safe apneoic time (pregnancy, morbid obesity, sepsis, active lung disease)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Center
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: Accuracy of Placement and Performance Test in Detecting Supraglottic Airway Placement Compared to Fiberoptic View
The goal of this cross sectional observational study is to compare the accuracy of placement and performance tests to gold standard method of fiberscope assisted insertion of Supraglottic Airway(SGA) Device for optimal SGA placement, in ASA 1-3 adult patients undergoing general anesthesia in University Malaya Medical Center(UMMC). This study aim to answer:
-Can placement and performance tests, ie; Oropharyngeal leak(OPL) test, accurately assess for optimal SGA placement?
- Being tested
- fiberoptic view of glottis
- Keywords
- Supraglottic airway placement tests, Supraglottic airway performance tests, Fiberscope grading for supraglottic airway placement, Oropharyngeal leak test(OPL test), Supraglottic Airway (SGA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiberoptic view of glottisDiagnostic test
fiberscope inserted through ventilation opening and place tip at glottis to capture view.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing general anesthesia with supraglottic airway | Not described Receives: Diagnostic Test: fiberoptic view of glottis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Oropharyngeal leak (OPL) test in determining optimal SGA placement
OPL test is part of the listed performance test done to evaluate ideal SGA placement and function for ventilation of GA patients.
It is measured in cmH20. Positive test is indicated when the value is >25cmH20.
Measured: From enrollment until end of surgery in recovery.
Secondary outcomes (7)
Accuracy of gastric test in evaluating optimal SGA placement.
Lubricant gel applied over gastric outlet of SGA. Positive test(abnormal) indicated when presence of gel movement seen during positive pressure ventilation.
Measured: from enrollment until end of surgery, in recovery.
Accuracy of suprasternal notch test in evaluating optimal SGA placement.
Lubricant gel applied over gastric outlet of SGA. Downward pressure applied over patient's suprasternal notch. Positive test(abnormal) indicated absent of movement with suprasternal notch pressure.
Measured: from enrollment until end of surgery, in recovery.
Accuracy of Maximal minute ventilation test in evaluating optimal SGA placement.
After general anesthesia and SGA insertion, manual positive pressure ventilation bagging done with APL valve set at 30cmH20 by providing 4 maximal insufflation breaths within 15 seconds and extrapolate to calculate minute ventilation(ml/min).
Positive test(abnormal) indicated when <12L/min.
Measured: from enrollment until end of surgery, in recovery.
Accuracy of subjective assessment(chest rise) in evaluating optimal SGA placement.
After general anesthesia and SGA placement, chest rise observed visually with positive pressure ventilation Positive test(abnormal) is indicated when no chest rise observed.
Measured: from enrollment until end of surgery, in recovery.
Accuracy of subjective assessment(expired tidal volume) in evaluating optimal SGA placement.
After general anesthesia and SGA placement, using volume controlled ventilation from GA machine, expired tidal volume is measured (ml).
Positive test(abnormal) is indicated when tidal volume is less than 6ml/kg of predicted body weight of patients.
Measured: from enrollment until end of surgery, in recovery.
Accuracy of subjective assessment(end tidal CO2 waveform) in evaluating optimal SGA placement.
After general anesthesia and SGA placement, while using Volume controlled ventilation via GA machine, end tidal CO2 waveform is observed.
Positive test(abnormal) is indicated when absence of square waveform pattern of et-CO2.
Measured: from enrollment until end of surgery, in recovery.
Accuracy of subjective assessment(audible leak) in evaluating optimal SGA placement.
After general anesthesia and SGA placement, stethoscope placed near oral cavity to appreciate for presence of leakage.
Positive test(abnormal) is when leakage heard with stethoscope.
Measured: from enrollment until end of surgery, in recovery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start14 Aug 2025
- Primary completion4 Sep 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraglottic Airways for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jeremy Dr tan, MBBS, Study chair, University Malaya Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726472
- Sponsor's protocol ID
- 2025312-14852
- Status last verified
- Mar 2026
- First submitted
- 22 Jun 2026
- Last updated
- 24 Jul 2026
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Placement and Performance Test in Detecting Supraglottic Airway Placement Compared to Fiberoptic View
- ClinicalTrials.gov ID
- NCT07726472
- Acronym / sponsor ID
- 2025312-14852
- Keywords
- Supraglottic airway placement tests, Supraglottic airway performance tests, Fiberscope grading for supraglottic airway placement, Oropharyngeal leak test(OPL test), Supraglottic Airway (SGA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 24 Jul 2026 (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 goal of this cross sectional observational study is to compare the accuracy of placement and performance tests to gold standard method of fiberscope assisted insertion of Supraglottic Airway(SGA) Device for optimal SGA placement, in ASA 1-3 adult patients undergoing general anesthesia in University Malaya Medical Center(UMMC). This study aim to answer:
-Can placement and performance tests, ie; Oropharyngeal leak(OPL) test, accurately assess for optimal SGA placement?
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing general anesthesia with supraglottic airway | – | Diagnostic Test: fiberoptic view of glottis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing general anesthesia with supraglottic ariway(SGA) in University Malaya Medical Center(UMMC)
Key inclusion criteria (1 listed)
- American Society of Anesthesiology(ASA) class 1-3.
Key exclusion criteria (5 listed)
- Patients with limited mouth opening.
- Patients with pharyngeal or laryngeal abnormalities that affect SGA placement.
- Patients with high risk of aspiration (gastroparesis, inadequate fasting time, hiatal hernia)
- Patients with reduced lung or chest compliance or increase airway resistance (ARDS, asthma)
- Patients with lower safe apneoic time (pregnancy, morbid obesity, sepsis, active lung disease)
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 |
|---|---|---|
| fiberoptic view of glottisfiberscope inserted through ventilation opening and place tip at glottis to capture view. | Diagnostic test | patients undergoing general anesthesia with supraglottic airway |
Primary outcome
Accuracy of Oropharyngeal leak (OPL) test in determining optimal SGA placement
Time frame: From enrollment until end of surgery in recovery.
OPL test is part of the listed performance test done to evaluate ideal SGA placement and function for ventilation of GA patients. It is measured in cmH20. Positive test is indicated when the value is >25cmH20.
7 secondary outcomes
Accuracy of gastric test in evaluating optimal SGA placement.
Time frame: from enrollment until end of surgery, in recovery.
Accuracy of suprasternal notch test in evaluating optimal SGA placement.
Time frame: from enrollment until end of surgery, in recovery.
Accuracy of Maximal minute ventilation test in evaluating optimal SGA placement.
Time frame: from enrollment until end of surgery, in recovery.
Accuracy of subjective assessment(chest rise) in evaluating optimal SGA placement.
Time frame: from enrollment until end of surgery, in recovery.
Accuracy of subjective assessment(expired tidal volume) in evaluating optimal SGA placement.
Time frame: from enrollment until end of surgery, in recovery.
Accuracy of subjective assessment(end tidal CO2 waveform) in evaluating optimal SGA placement.
Time frame: from enrollment until end of surgery, in recovery.
Accuracy of subjective assessment(audible leak) in evaluating optimal SGA placement.
Time frame: from enrollment until end of surgery, in recovery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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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.
jeremy Dr tan, MBBS study chair
University Malaya Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supraglottic Airways for General Anesthesia, run by University of Malaya at 1 site in Malaysia.
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 5 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: finished, as of the sponsor's last update on 24 Jul 2026. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Oropharyngeal leak (OPL) test in determining optimal SGA placement (time frame: From enrollment until end of surgery in recovery.). 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 24 Jul 2026.