Supraglottic Airway Devices Position
Conditions
Keywords
supraglottic airway device, laryngeal mask
Brief summary
This study aims to compare the new-generation GMA laryngeal mask airway (LMA) with the traditional inflatable LMA in patients undergoing elective surgery under general anesthesia. The primary objectives are to evaluate the safety, effectiveness, stability, ease of use, and patient comfort of the GMA LMA, providing practical guidance for clinical airway management. Additionally, this research will analyze the anatomical positioning and sealing mechanism of the LMA to identify factors influencing proper alignment and airway sealing. The findings may contribute to future improvements in LMA design, enhancing patient safety and procedural success. This study is designed for healthcare providers, anesthesiologists, and researchers seeking evidence-based recommendations for LMA selection in clinical practice. Participation involves standard anesthesia procedures with close monitoring to ensure patient safety.
Detailed description
Eligible patients meeting the inclusion criteria were enrolled in the study and randomly assigned into two groups using a random number table: the traditional Inflatable Laryngeal Mask Airway Group (Group L) and the GMA Group (Group G). One day before surgery, the research team conducted preliminary screening of patients scheduled for elective surgery, followed by a preoperative visit to explain the study's purpose, anesthesia considerations, and obtain informed consent. Upon entering the operating room, standard monitoring (ECG, blood pressure, pulse oximetry, etc.) was applied. The research team recorded the patient's actual fasting duration, last intake (food/liquid type), and baseline characteristics, including age, sex, height, weight, BMI, comorbidities, ASA classification, surgical type, and preoperative anxiety level. Airway assessment was reconfirmed. Anesthesia induction was performed with intravenous etomidate, vecuronium, and sufentanil. After loss of consciousness and disappearance of the eyelash reflex, manual ventilation was initiated. Following induction, the laryngeal mask was inserted.
Interventions
DEVICEGMA Laryngeal Mask Airway
The GMA-Tulip is a new single-use supraglottic airway device (SAD). Device size is selected based on the patient's weight and height, following manufacturer guidelines.
DEVICEInflatable Laryngeal Mask Airway
The comparator is a conventional inflatable Laryngeal Mask Airway (LMA) of appropriate size (selected by weight/height), inserted using standard clinical protocols.
Sponsors
First Affiliated Hospital of Zhejiang University
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Red Cross Hospital, Hangzhou, China
Hangzhou Hospital of Traditional Chinese Medicine
Lanxi People's Hospital
Ningbo Medical Center Lihuili Hospital
The Second Affiliated Hospital of Jiaxing University
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Ruijin Hospital
The Central Hospital of Lishui City
Lishui Country People's Hospital
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria 1. Age 18-75 years; 2. ASA physical status I-II; 3. Strict compliance with ASA fasting guidelines; 4. Normal airway anatomy; 5. Voluntary participation with signed informed consent. *
Exclusion criteria
1. Pre-existing aspiration risk or gastrointestinal disorders; 2. Oropharyngeal/laryngeal abnormalities; 3. Anticipated difficult airway (≥1 of the following): BMI \>30 kg/m² Mouth opening \<3 cm Mallampati class III-IV Restricted neck mobility 4. Contraindications to LMA use; 5. Communication or cognitive impairments; 6. Other exclusions at investigator's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of anatomical alignment of laryngeal mask | During LMA placement (immediately after insertion) | Comparison of anatomical positioning success rates between inflatable LMA and GMA-Tulip LMA, assessed by fiberoptic bronchoscopy (FOB). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sealing pressure and positional stability of the GMA-Tulip versus inflatable LMA | Intraoperative period (from LMA insertion until removal at end of surgery) | Assess the stability and anti-displacement properties of special body positions (e.g. lateral decubitus, Trendelenburg position) and the laryngeal mask airway under pneumoperitoneum. |
| First-attempt success rate of LMA | during procedure | First-attempt success: Successful placement of the laryngeal mask airway on the first attempt without requiring reinsertion |
| Time to Successful Placement of LMA | during procedure | Duration (in seconds) from LMA insertion into the oral cavity until final correct positioning is achieved |
| Hemodynamic response to LMA insertion and removal | Intraoperative period | Parameters: Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) (measured non-invasively or invasively). |
| Oxygenation Stability (Intraoperative) | From patient entry into operating room to the time for LMA removal | Peripheral oxygen saturation (SpO₂) (%) measured by continuous pulse oximetry |
| Ventilation Parameters (Intraoperative) | from the start of mechanical ventilation after LMA placement to LMA removal | The measurement of Peak Airway Pressure (Ppeak) in cmH₂O is typically obtained through real-time monitoring by the anesthesia machine's ventilator system. |
| Feasibility of gastric tube insertion through LMA | During LMA placement (after confirmation of correct LMA position). | Success rate: Proportion of cases with successful gastric tube placement |
| LMA-Related Complications | Day 0 | Immediate complications: Visible blood on removal (graded: none/mild/moderate/severe), sore throat , hoarseness, aspiration. Pain assessment: NRS for sore throat . |
| Patient Tolerance Score | Within 60 minutes after LMA removal | Grade I (Excellent Tolerance) to Grade IV (Severe Intolerance) |
| Anesthesiologist Satisfaction Survey | Within 30 minutes after surgery completion | Scale: 1-10 (1 = Very dissatisfied, 10 = Very satisfied) |
| Surgeon Satisfaction Assessment | Within 30 minutes after surgery completion | Scale: 1-10 (1 = Very dissatisfied, 10 = Very satisfied) |
| Patient Satisfaction Survey | Within 24 hours after surgery | Scale: 1-10 (1 = Very uncomfortable, 10 = Very comfortable) |
| Ultrasonographic Assessment of Gastric Antrum Cross-Sectional Area (CSA) in Supine Position for Monitoring Gastric Insufflation | Baseline: Within 10 minutes before anesthesia induction; Post-intervention: Within 3 minutes after successful LMA placement; Postoperative: After surgical closure but before LMA removal | This protocol utilizes point-of-care ultrasound (POCUS) to measure gastric antrum cross-sectional area (CSA) in supine patients, evaluating the risk of perioperative gastric insufflation caused by LMA. |
Countries
China
Contacts
CONTACTXiangming Fang, Doctor
PRINCIPAL_INVESTIGATORXiangming Fang
Zhejiang University
Outcome results
None listed