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.
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.
After the anesthesia induction, use the GMA-TULIP laryngeal mask as the airway ventilation device.
After the anesthesia induction, use the i-gel laryngeal mask as an airway ventilation device.
After the anesthesia induction is over, use the BlockBuster laryngeal mask as the airway ventilation device.
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGoropharyngeal leak pressure
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.
Time frame: 1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position
The rate of first-insertion success
The successful insertion is defined as oropharyngeal leak pressure higher than 20 cmH2O and grade 1-2 of the laryngeal view under the fibreoptic bronchoscopy (indicating the accuracy of laryngeal mask positioning).
Time frame: 1 minute after the first-attempt insertion of the laryngeal mask
The rate of total-insertion success
The total successful insertion is defined as ventilation with the allocated laryngeal mask after anesthesia induction
Time frame: 1 minute after the airway is successfully controlled.
Time of insertion
Insertion time was defined as the time from the opening of the mouth by the operator to the positively insert the laryngeal mask. The time of glottic examination, adjustment between two ventilation insertions, and ventilation was not measured as ventilation insertion time.
Time frame: 1 minute after successful insertion of the laryngeal mask
Times of laryngeal mask adjustment before the successful insertion
The times of laryngeal mask adjustments before successful laryngeal mask insertion.
Time frame: 1 minute after the airway is successfully controlled.
Success rate of gastric tube insertion through laryngeal mask
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
102
After the laryngeal mask is successful inserted, a fully lubricated 14F gastric tube was inserted through its esophageal drainage tube
Time frame: 1 minute after the laryngeal mask is successful inserted
Airway plateau pressure
Plateau airway pressure refers to the pressure that a certain amount of gas remains in the lungs against the entire closed system at the end of the passage of air, before the beginning of exhalation. Airway plateau pressure was measured by the anesthesia machine automatically.
Time frame: 1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position
Peak airway pressure
Peak pressure refers to the maximum pressure produced by the airflow in the closed circuit each time the ventilator delivers a certain amount of gas from the endotracheal tube to the patient's lungs. Peak airway pressure was measured by the anesthesia machine automatically.
Time frame: 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)
After successful insertion of the laryngeal mask, fiberoptic bronchoscopy was used and graded according to the degree of glottic and epiglottis exposure by a 4-point scale system: 1, full view of glottis; 2, vocal cords, arytenoids, and inferior surface of epiglottis visible; 3, only superior surface of epiglottis visible; 4, no part of epiglottis or larynx visible. The grades 1 and 2 were defined as optimal fiberscopic view.
Time frame: 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
the times of the laryngeal mask adjustment during the operation were recorded
Time frame: From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia
Times of intraoperative air leakage
intraoperative air leakage is defined as hearing the sound of air leakage at the neck during the operation
Time frame: From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia
Active mouth bleeding rate
After the laryngeal mask was removed, record whether active bleeding occurred at the patient's mouth
Time frame: 1 minute after laryngeal mask removal
incidence of blood staining on the laryngeal mask
When the laryngeal mask was pulled out, the laryngeal mask was stained with blood
Time frame: 1 minute after the laryngeal mask was withdrawn
The incidence of regurgitation
The regurgitation is defined as seeing the gastric content in the mouth
Time frame: From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia
The incidence of aspiration
The aspiration is defined as seeing the gastric content in the trachea
Time frame: From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia
The incidence of cough
When the laryngeal mask was pulled out, record whether the patient has cough or not.
Time frame: From 5 minutes before to 5 minutes after the laryngeal mask withdrawal.
Severity of sore throat
The Prince-Henry score was used to evaluate the degree of sore throat: 0, no pain when coughing; 1, pain only when coughing; 2, pain when breathing deeply, but not at rest; 3, pain at rest, but mild and tolerable; 4, excruciating pain at rest, respectively.
Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
Length of surgery
The end of the surgery time minus the start of the surgery time
Time frame: 1 minute after the end of surgery
Time of laryngeal mask application
The time of laryngeal mask withdrawn minus the time of successful laryngeal mask insertion is the time of laryngeal mask application
Time frame: 1 minute after the laryngeal mask is withdrawn
The incidence of hoarseness
Record whether the patient is hoarse when speaking
Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
The incidence of dysphagia
Check the patient can swallow or not
Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
Heart rate
Heart rate
Time frame: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn
systolic blood pressure
systolic blood pressure
Time frame: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn
diastolic blood pressure
diastolic blood pressure
Time frame: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn
mean arterial pressure
mean arterial pressure
Time frame: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn