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.

NCT07726472 | Completed

• 1 other identifier: 2025312-14852
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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?

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment until end of surgery in recovery.

Secondary Outcomes (7)

• Accuracy of gastric test in evaluating optimal SGA placement.

  from enrollment until end of surgery, in recovery.

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

  from enrollment until end of surgery, in recovery.

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

  from enrollment until end of surgery, in recovery.

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

  from enrollment until end of surgery, in recovery.

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

  from enrollment until end of surgery, in recovery.

Study Arms (1)

patients undergoing general anesthesia with supraglottic airway

Diagnostic Test: fiberoptic view of glottis

Interventions

fiberoptic view of glottis DIAGNOSTIC_TEST

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

patients undergoing general anesthesia with supraglottic airway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing general anesthesia with supraglottic ariway(SGA) in University Malaya Medical Center(UMMC)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Center

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Study Officials

• jeremy Dr tan, MBBS

  University Malaya Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 24, 2026
• Study Start: August 14, 2025
• Primary Completion: September 4, 2025
• Study Completion: November 28, 2025
• Last Updated: July 24, 2026

Record last verified: 2026-03

Locations

MY (1)