The First affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
Location contact
Bingduo Wang, M.D.
CONTACT
Xiangming Fang, M.D.
PRINCIPAL_INVESTIGATOR
Xiaoxia An, M.D.
CONTACT
NCT Number: NCT07177586
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
Bingduo Wang, M.D.
CONTACT
Xiangming Fang, M.D.
PRINCIPAL_INVESTIGATOR
Xiaoxia An, M.D.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
BMI >30 kg/m² Mouth opening <3 cm Mallampati class III-IV Restricted neck mobility
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.
Other names: GMA-Tulip LMA
The comparator is a conventional inflatable Laryngeal Mask Airway (LMA) of appropriate size (selected by weight/height), inserted using standard clinical protocols.
Other names: Cuffed Supraglottic Airway
Time frame: During LMA placement (immediately after insertion)
Comparison of anatomical positioning success rates between inflatable LMA and GMA-Tulip LMA, assessed by fiberoptic bronchoscopy (FOB).
Time frame: 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.
Time frame: during procedure
First-attempt success: Successful placement of the laryngeal mask airway on the first attempt without requiring reinsertion
Time frame: during procedure
Duration (in seconds) from LMA insertion into the oral cavity until final correct positioning is achieved
Time frame: Intraoperative period
Parameters: Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) (measured non-invasively or invasively).
Time frame: From patient entry into operating room to the time for LMA removal
Peripheral oxygen saturation (SpO₂) (%) measured by continuous pulse oximetry
Time frame: 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.
Time frame: During LMA placement (after confirmation of correct LMA position).
Success rate: Proportion of cases with successful gastric tube placement
Time frame: Day 0
Immediate complications: Visible blood on removal (graded: none/mild/moderate/severe), sore throat , hoarseness, aspiration.
Pain assessment: NRS for sore throat .
Time frame: Within 60 minutes after LMA removal
Grade I (Excellent Tolerance) to Grade IV (Severe Intolerance)
Time frame: Within 30 minutes after surgery completion
Scale: 1-10 (1 = Very dissatisfied, 10 = Very satisfied)
Time frame: Within 30 minutes after surgery completion
Scale: 1-10 (1 = Very dissatisfied, 10 = Very satisfied)
Time frame: Within 24 hours after surgery
Scale: 1-10 (1 = Very uncomfortable, 10 = Very comfortable)
Time frame: 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.
Contact information is provided by the study sponsor or research team.
First Affiliated Hospital of Zhejiang University
Other
A Multicenter, Randomized Controlled Study Comparing the Effectiveness of the New Generation GMA Laryngeal Mask and Conventional Laryngeal Mask in Airway Management During General Anesthesia
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.
Published trials that share one or more normalized conditions with this study.
NCT06775184
Supraglottic Airway Devices Position
View Trial Details