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临床试验/NCT06782841
NCT06782841招募中不适用

The Effects of GMA-TULIP, I-gel, and BlockBuster Laryngeal Mask in Surgeries With Lateral Position Under General Anesthesia

The Second Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年8月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
102
试验地点
1
主要终点
oropharyngeal leak pressure

研究概览

简要总结

To compare the efficacy and safety of traditional inflatable laryngeal mask, i-gel non-inflatable laryngeal mask and GMA-TULIP non-inflatable laryngeal mask in surgeries with lateral position under general anesthesia, so that providing evidence for the selection of laryngeal mask in surgeries with lateral position.

详细描述

Laryngeal mask and tracheal intubation are the two most commonly used airway management methods for patients under general anesthesia. Compared with tracheal intubation, laryngeal mask is only placed in the throat without the need for laryngoscope to expose the glottis, not entering the glottis and trachea, so it will not cause mechanical damage to the vocal cords and trachea. Moreover, the insertion of laryngeal mask reduces the excitation of sympathetic and vagus nerves, has a relatively mild effect on physiological status, and significantly reduces cardiovascular reactions, which is convenient for maintaining hemodynamic stability during anesthesia induction and patients can tolerate the tube better without coughing or agitation during recovery from the anesthesia. Therefore, laryngeal masks are currently widely used in airway management during general anesthesia. Studies have shown that about 3 million patients in the UK National Health Service system receive anesthesia surgery with different types of airway management every year, and the use of laryngeal masks is higher than that of tracheal intubation, accounting for about 56.2%.

Since its introduction, many new laryngeal masks have been improved and applied to clinical practice based on the classic laryngeal mask. A key indicator for evaluating the performance of laryngeal masks is their sealing effect on the airway. Currently, laryngeal masks are mainly divided into two categories: inflatable laryngeal masks and non-inflatable laryngeal masks. Inflatable laryngeal masks are traditional types, including BlockBuster, Superme, ProSeal, and Fastrach, which are the most widely used in clinical practice. Non-inflatable laryngeal masks are designed with a mirror image of the throat opening and use thermoplastic elastomer materials to achieve a gas tightness effect similar to that of inflatable laryngeal masks. The i-gel laryngeal mask is currently the most commonly used non-inflatable type. A meta-analysis found that the sealing pressure of the i-gel laryngeal mask is higher than that of traditional inflatable laryngeal masks, indicating better airway sealing performance for non-inflatable laryngeal masks. The GMA-TULIP non-inflatable laryngeal mask is a new type of non-inflatable laryngeal mask with advantages such as a C-shaped double gastric tube channel, a stable platform for the tongue base, a soft tissue sealing ring, a prominent epiglottis attachment, and a design that matches the anatomical structure of the throat opening. Compared with inflatable laryngeal masks, the GMA-TULIP mask is more in line with anatomical positioning design, theoretically providing higher sealing effect on the airway.

Although the laryngeal mask has been successfully applied to the airway management of surgeries with lateral position under general anesthesia, its widespread use is limited due to the special position of lateral position, which may lead to laryngeal mask displacement, poor airway tightness, and air leakage. Therefore, exploring a laryngeal mask with better airway sealing effect in surgeries with lateral position under general anesthesia will help promote the clinical application of laryngeal mask, reduce airway injury and hemodynamic fluctuation, and improve patient comfort. To this end, this project plans to compare the application effects of traditional inflatable BlockBuster laryngeal mask, i-gel non-inflatable laryngeal mask, and GMA-TULIP non-inflatable laryngeal mask in surgeries with lateral position under general anesthesia, providing clinical evidence for the selection of laryngeal mask in surgeries with lateral position under general anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients received surgeries in lateral position with an estimated surgery duration of less than 3 hours under general anesthesia.
  • •Ages between 18 to 80, and body mass index less than 28 kg/m².
  • •American Society of Anesthesiologists (ASA) Grades I-III.
  • •Patients are willing to participate and be able to understand and sign an informed consent form.

排除标准

  • •Individuals with an open bite of less than 2cm.
  • •Individuals with a history of obvious regurgitation of gastric contents and risk factors for aspiration.
  • •Patients with combined pharyngeal and laryngeal lesions.
  • •Predicting difficult airway patients.
  • •Hearing, intellectual, communication, and cognitive impairments.
  • •Any reason that prevents cooperation with the study or that the researcher deems inappropriate for inclusion in this trial.

研究组 & 干预措施

GMA-TULIP Laryngeal Mask Group(D1 Group)

Experimental

After the anesthesia induction, use the GMA-TULIP laryngeal mask as the airway ventilation device.

干预措施: GMA-TULIP Laryngeal Mask (Device)

i-gel Laryngeal Mask Group(D2 Group)

Active Comparator

After the anesthesia induction, use the i-gel laryngeal mask as an airway ventilation device.

干预措施: i-gel Laryngeal Mask (Device)

BlockBuster Laryngeal Mask Group(D3 Group)

Active Comparator

After the anesthesia induction is over, use the BlockBuster laryngeal mask as the airway ventilation device.

干预措施: BlockBuster Laryngeal Mask (Device)

结局指标

主要结局

oropharyngeal leak pressure

时间窗: 1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position

After the laryngeal mask is successful inserted, set the fresh gas flow to 3 L/min in manual mode, turn the APL valve to 30 cmH2O, then listen to the neck. When hearing the sound of air leakage, the peak airway pressure at this time is the oropharyngeal leak pressure.

次要结局

  • The incidence of dysphagia(10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery)
  • The rate of first-insertion success(1 minute after the first-attempt insertion of the laryngeal mask)
  • The rate of total-insertion success(1 minute after the airway is successfully controlled.)
  • Time of insertion(1 minute after successful insertion of the laryngeal mask)
  • Times of laryngeal mask adjustment before the successful insertion(1 minute after the airway is successfully controlled.)
  • Success rate of gastric tube insertion through laryngeal mask(1 minute after the laryngeal mask is successful inserted)
  • Airway plateau pressure(1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position)
  • Peak airway pressure(1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position)
  • grade of view on fibreoptic bronchoscopy (indicating the accuracy of laryngeal mask positioning)(1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position)
  • Times of laryngeal mask adjustment during the operation(From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia)
  • Times of intraoperative air leakage(From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia)
  • Active mouth bleeding rate(1 minute after laryngeal mask removal)
  • incidence of blood staining on the laryngeal mask(1 minute after the laryngeal mask was withdrawn)
  • The incidence of regurgitation(From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia)
  • The incidence of aspiration(From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia)
  • The incidence of cough(From 5 minutes before to 5 minutes after the laryngeal mask withdrawal.)
  • Severity of sore throat(10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery)
  • Length of surgery(1 minute after the end of surgery)
  • Time of laryngeal mask application(1 minute after the laryngeal mask is withdrawn)
  • The incidence of hoarseness(10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery)
  • Heart rate(1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn)
  • systolic blood pressure(1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn)
  • diastolic blood pressure(1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn)
  • mean arterial pressure(1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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