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Completed

NCT Number: NCT06383494

GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management (GLAM-I)

Patients were randomly assigned to three supraglottic airway devices (SADs) groups for airway management after anesthesia induced. Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed and other airway management quality was recorded.

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Key information

Conditions

Anesthesia Airway Remodeling Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

About this study

Mechanical ventilation was volume controlled and time cycled with tidal volumes (6-8 ml/kg) set to maintain peak inspiratory pressures of less than 20 cm H2O and ventilatory frequency adjusted to maintain end-tidal carbon dioxide (PETCO2) at 35-45 mmHg. Then a fiberoptic bronchoscope was passed through airway tube into the device to perform glottic exposure grading. Peak airway pressure, incidence of pharyngalgia, bleeding, hoarseness, and dysphagia were recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-75 years old;
  • American Society of Anesthesiologists (ASA) I-III;
  • Body mass index (BMI)<30Kg/m2;
  • Scheduled for elective breast or lower abdominal surgery with an estimated duration of less than 4 hours;
  • Providing written inform consent.

Exclusion criteria

  • History of oropharyngeal surgery and anatomical abnormalities;
  • Limited movement of the cervical spine;
  • High risk of reflux/aspiration;
  • Emergency surgery;
  • Acute throat inflammation and upper respiratory infection;
  • History of chronic bronchitis or asthma;
  • Cognitive dysfunction and inability to communicate;
  • Participating in other clinical trials.

Treatment and study plan

LMA supreme group

Device

Patient in this group received LMA supreme (one of laryngeal airway management device) for airway management during general anesthesia

I-gel group

Device

Patient in this group received I-gel laryngeal (one of laryngeal airway management device) for airway management during general anesthesia

GMA-TULIP

Device

Patient in this group received GMA-Tulip (one of laryngeal airway management device) for airway management during general anesthesia

Primary outcomes

  1. Glottic exposure grading

    Time frame: From the insertion of supraglottic airway device to the end of surgery.

    Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed.

Secondary outcomes

  1. Peak inspiratory pressures

    Time frame: From the insertion of supraglottic airway device to 15 minutes after insertion.

    Record peak airway pressure during surgery.

  2. Plateau inspiratory pressures

    Time frame: From the insertion of supraglottic airway device to 15 minutes after insertion.

    Record plateau airway pressure during surgery.

  3. Oropharyngeal leak pressure

    Time frame: From the insertion of supraglottic airway device to 30 minutes after insertion

    Measure the oropharyngeal leak pressure after insertion of supraglottic airway device

  4. Oropharyngeal leak pressure at 30 and 45 degrees of head rotation

    Time frame: From the insertion of supraglottic airway device to 30 minutes after insertion

    Measure the oropharyngeal leak pressure at 30 and 45 degrees of head rotation after insertion of supraglottic airway device

  5. Ventilation quality

    Time frame: From the insertion of supraglottic airway device to 15 minutes after insertion

    Record the ventilation quality after the insertion of supraglottic airway device. In specific, The Ventilation Quality Score consists of three components: presence of normal CO₂ waveform, bilateral symmetrical chest rise, and absence of air leak at 20 mmHg airway pressure. Total scores range 0-3, with 0 indicating poor ventilation quality and 3 representing optimal ventilation.

  6. Abnormally ventilation events during surgery

    Time frame: From the insertion of supraglottic airway device to the end of surgery

    Record the abnormally ventilation events (air leakage, abnormal carbon dioxide wave, higher airway pressure, hypoxemia, supraglottic airway device adjustment, change into intubation) during surgery

  7. Side effects at the end of surgery

    Time frame: From the insertion of supraglottic airway device to the patient's transfer to the ward. An average of 3 hours.

    Record side effects (blooding on the supraglottic airway device, pharyngalgia, hoarseness) at the end of surgery.

  8. Side effects and adverse events 24 hours after surgery

    Time frame: Postoperative day 1.

    Record side effects (pharyngalgia, hoarseness, cough when drinking), and adverse events (pneumonia, hypoxemia) 24 hours after surgery.

  9. Nasogastric tube insertion success rate

    Time frame: From the initial insertion to the successful placement of nasogastric tube. An average of 20 minutes.

    Record the nasogastric tube insertion success rate

  10. Nasogastric tube insertion attempts

    Time frame: From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.

    Record the number of attempts for nasogastric tube insertion

  11. Nasogastric tube insertion time

    Time frame: From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.

    Record the duration (seconds from insertion initiation to successful placement) of nasogastric tube insertion

  12. Nasogastric tube insertion difficulty

    Time frame: From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.

    Record the insertion difficulty (1-3 scale; 1=easy, 3=difficult) of nasogastric tube placement

  13. Reflux or aspiration risk

    Time frame: From the insertion of s SAD to the end of surgery. An average of 3 hours.

    Record gas/fluid volume during the surgery

  14. Supraglottic airway device insertion duration

    Time frame: From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds.

    Record the insertion duration (seconds from insertion initiation to successful placement) of SADs

  15. Supraglottic airway device insertion difficult

    Time frame: From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds.

    Record the insertion difficulty (1-3 scale; 1=easy, 3=difficult) of SADs

  16. Supraglottic airway device insertion times

    Time frame: From the mouth open to the device seated upon encountering resistance or able to ventilation after device's adjustment/reinsertion, averaging approximately 10 seconds.

    Record the number of SAD insertion attempts.

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management Under General Anesthesia, a Randomized Controlled Study (GLAM-I)

Acronym: GLAM-I

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 25, 2024
Registry last updated
Jan 8, 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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