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NCT Number: NCT07726472

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.

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?

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Key information

Conditions

Supraglottic Airways for General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

fiberoptic view of glottis

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Accuracy of gastric test in evaluating optimal SGA placement.

    Time frame: 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.

  2. Accuracy of suprasternal notch test in evaluating optimal SGA placement.

    Time frame: 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.

  3. Accuracy of Maximal minute ventilation test in evaluating optimal SGA placement.

    Time frame: 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.

  4. Accuracy of subjective assessment(chest rise) in evaluating optimal SGA placement.

    Time frame: 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.

  5. Accuracy of subjective assessment(expired tidal volume) in evaluating optimal SGA placement.

    Time frame: 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.

  6. Accuracy of subjective assessment(end tidal CO2 waveform) in evaluating optimal SGA placement.

    Time frame: 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.

  7. Accuracy of subjective assessment(audible leak) in evaluating optimal SGA placement.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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