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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.

Accuracy of Placement and Performance Test in Detecting Supraglottic Airway Placement Compared to Fiberoptic View

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07726472
Enrollment
30
Registered
2026-07-24
Start date
2025-08-14
Completion date
2025-11-28
Last updated
2026-07-24

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

Conditions

Supraglottic Airways for General Anesthesia

Keywords

Supraglottic airway placement tests, Supraglottic airway performance tests, Fiberscope grading for supraglottic airway placement, Oropharyngeal leak test(OPL test), Supraglottic Airway (SGA)

Brief 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 Center(UMMC). This study aim to answer: -Can placement and performance tests, ie; Oropharyngeal leak(OPL) test, accurately assess for optimal SGA placement?

Interventions

DIAGNOSTIC_TESTfiberoptic view of glottis

fiberscope inserted through ventilation opening and place tip at glottis to capture view.

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* American Society of Anesthesiology(ASA) class 1-3.

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of Oropharyngeal leak (OPL) test in determining optimal SGA placementFrom 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.

Secondary

MeasureTime frameDescription
Accuracy of gastric test in evaluating optimal SGA placement.from enrollment until end of surgery, in recovery.Lubricant gel applied over gastric outlet of SGA. Positive test(abnormal) indicated when presence of gel movement seen during positive pressure ventilation.
Accuracy of suprasternal notch test in evaluating optimal SGA placement.from enrollment until end of surgery, in recovery.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.
Accuracy of Maximal minute ventilation test in evaluating optimal SGA placement.from enrollment until end of surgery, in recovery.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.
Accuracy of subjective assessment(chest rise) in evaluating optimal SGA placement.from enrollment until end of surgery, in recovery.After general anesthesia and SGA placement, chest rise observed visually with positive pressure ventilation Positive test(abnormal) is indicated when no chest rise observed.
Accuracy of subjective assessment(expired tidal volume) in evaluating optimal SGA placement.from enrollment until end of surgery, in recovery.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.
Accuracy of subjective assessment(end tidal CO2 waveform) in evaluating optimal SGA placement.from enrollment until end of surgery, in recovery.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.
Accuracy of subjective assessment(audible leak) in evaluating optimal SGA placement.from enrollment until end of surgery, in recovery.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.

Countries

Malaysia

Contacts

STUDY_CHAIRjeremy Dr tan, MBBS

University Malaya Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026