New-Generation GMA Laryngeal Mask Airway Versus Conventional Inflatable Laryngeal Mask Airway

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство GMA 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.
• Устройство Inflatable 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.

Первичные конечные точки

• Success rate of anatomical alignment of laryngeal mask [Срок оценки: During LMA placement (immediately after insertion)]

Вторичные конечные точки (12)

• Sealing pressure and positional stability of the GMA-Tulip versus inflatable LMA [Срок оценки: Intraoperative period (from LMA insertion until removal at end of surgery)]
• First-attempt success rate of LMA [Срок оценки: during procedure]
• Time to Successful Placement of LMA [Срок оценки: during procedure]
• Hemodynamic response to LMA insertion and removal [Срок оценки: Intraoperative period]
• Oxygenation Stability (Intraoperative) [Срок оценки: From patient entry into operating room to the time for LMA removal]
• Ventilation Parameters (Intraoperative) [Срок оценки: from the start of mechanical ventilation after LMA placement to LMA removal]
• Feasibility of gastric tube insertion through LMA [Срок оценки: During LMA placement (after confirmation of correct LMA position).]
• LMA-Related Complications [Срок оценки: Day 0]
• Patient Tolerance Score [Срок оценки: Within 60 minutes after LMA removal]
• Anesthesiologist Satisfaction Survey [Срок оценки: Within 30 minutes after surgery completion]
• Surgeon Satisfaction Assessment [Срок оценки: Within 30 minutes after surgery completion]
• Patient Satisfaction Survey [Срок оценки: Within 24 hours after surgery]

Критерии участия

Критерии включения

• Inclusion Criteria

• Age 18-75 years;
• ASA physical status I-II;
• Strict compliance with ASA fasting guidelines;
• Normal airway anatomy;
• Voluntary participation with signed informed consent.
• Exclusion Criteria:

• Pre-existing aspiration risk or gastrointestinal disorders;
• Oropharyngeal/laryngeal abnormalities;
• Anticipated difficult airway (≥1 of the following):

BMI >30 kg/m² Mouth opening <3 cm Mallampati class III-IV Restricted neck mobility

• Contraindications to LMA use;
• Communication or cognitive impairments;
• Other exclusions at investigator's discretion

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• The First affiliated Hospital, School of Medicine, Zhejiang University — Ханчжоу

Публикации

• Zheng J, Du L, Wang J, Zhang L, Chen G. Prewarming i-gel laryngeal mask for mechanical ventilation: a meta-analysis of randomised control trials and trial sequential analysis. BMJ Open. 2021 Aug 10;11(8):e045461. doi: 10.1136/bmjopen-2020-045461. PMID 34376440
• Luo K, Chen K, Li Y, Ji Y. Clinical evaluation of laryngeal mask airways in video-assisted thoracic surgery: a meta-analysis of randomized controlled trials. J Cardiothorac Surg. 2024 Jun 24;19(1):361. doi: 10.1186/s13019-024-02840-6. PMID 38915035
• Xu K, Zhang Y, Cui Y, Tian F. Patient-reported outcomes of laryngeal mask anesthesia in thoracoscopic pulmonary wedge resection: A randomized controlled study. Thorac Cancer. 2022 Nov;13(22):3192-3199. doi: 10.1111/1759-7714.14675. Epub 2022 Sep 30. PMID 36178200
• De Rosa S, Messina A, Sorbello M, Rigobello A, Colombo D, Piccolo A, Bonaldi E, Gennaro P, Urukalo V, Pellizzari A, Bonato R, Carboni SC. Laryngeal Mask Airway Supreme vs. the Spritztube tracheal cannula in anaesthetised adult patients: A randomised controlled trial. Eur J Anaesthesiol. 2019 Dec;36(12):955-962. doi: 10.1097/EJA.0000000000001106. PMID 31644512
• Wei CF, Chung YT. Laryngeal mask airway facilitates a safe and smooth emergence from anesthesia in patients undergoing craniotomy: a prospective randomized controlled study. BMC Anesthesiol. 2023 Jan 17;23(1):29. doi: 10.1186/s12871-023-01972-x. PMID 36650435

Идентификаторы

NCT: NCT07177586 · Laryngeal mask

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗