Clinical Study Of SaCoVLM Visual Laryngeal Mask For Children With Ear Deformities

Background:The laryngeal mask airway(LMA)is a new type of airway management tool commonly used in clinical practice,which has the advantages of simple operation,easy to master,small damage,good patient tolerance and so on.Although the double-lumen laryngeal mask has added many functions,its insertion process is no different from that of the first-generation laryngeal mask,and it is still a blind exploration operation.Although there are many advantages of laryngeal masks on the market,there are still many problems such as air leakage,airway failure,unstable fixation,mucosal injury of pharynx and larynx,nerve injury and reflux.Anesthesiologists still need to indirectly evaluate the model and position of the laryngeal mask according to a series of subjective and objective indicators.Even if all clinical verification methods suggest that the laryngeal mask is well positioned(regular chest fluctuation,laryngeal mask sealing pressure greater than 30 cmH2O),it cannot be determined whether the laryngeal mask is anatomically compatible with the airway.Congenital craniofacial deformities include congenital cranial suture closure,widened orbital distance,Apert syndrome,Crouzon syndrome,microtia,cleft lip and palate,which account for more than 60%of birth defects on the body surface.Patients with these types of conditions often have malformed lower jaw and temporomandibular joint deformity.Difficult airway management during anesthesia is often difficult to expose laryngoscopic view and difficult to intubate.The awake intubation technique used in pediatric difficult airway management is not well tolerated,so the difficulty of managing the airway in such children and the risk of respiratory system-related complications are obviously higher than in adults.The operation is more challenging.The laryngeal mask is comfortable to insert and can be used to guide tracheal intubation while ensuring ventilation,so the fornmulation of airway management strategies using laryngeal mask guidance is of great importance to ensure the safety of the patient.Existing adult difficult airway management guidelines indicate that the use of visual aids plays an important role in airway management.SaCoVLM visual laryngeal mask(UE Medical(?),Zhejiang,China)is a new type of domestic visual laryngeal mask.The built-in camera in the laryngeal mask can continuously observe the whole process of insertion,retention and removal of the laryngeal mask,and timely find out the problems in the process of laryngeal mask use,which provides great convenience for the safe use of laryngeal mask.Different from the previous visual laryngeal masks,SaCoVLM visual laryngeal mask can not only assist tracheal intubation,but also guide the positioning process of laryngeal mask through visual technology.However,SaCoVLM visual laryngeal mask is mainly used to maintain ventilation or endotracheal intubation in adults,and there is no relevant study on the application of visual laryngeal mask in children,and its effectiveness as a supraglottic ventilation tool to maintain ventilation in children remains to be evaluated,and the effectiveness and operation skills of guiding tracheal intubation in children need to be verified.Objectives:1.To observe the feasibility and safety of SaCoVLM visual laryngeal mask for tracheal intubation in children with ear deformity.2.To compare the clinical effect of SaCoVLM laryngeal mask with the Air-Q intubating laryngeal mask airway for the purposes of tracheal intubation in ear deformity children.3.To observe the effect of using a plastic stylet to adjust the curvature of the front end of SaCoVLM visual laryngeal mask on the insertion of the laryngeal mask aiming to provide reference for airway management of children with ear deformities.Methods and Results:Part 1:Clinical study of SaCoVLM visual laryngeal mask-guided tracheal intubation for children with ear deformities under general anesthesiaMethods:ASA class Ⅰ-Ⅱ children aged 5-14 years who underwent elective ear deformity surgery under general anesthesia were included.Choose the appropriate size of SaCoVLM visual laryngeal mask according to the weight,and select the appropriate type of endotracheal tube according to the age.After the laryngeal mask is placed in place,perform tracheal intubation under the guidance of the visual laryngeal mask.The mask stylet withdraws the laryngeal mask,retaining the endotracheal tube.Record the time,times and adjustment methods of laryngeal mask insertion,endotracheal intubation,and laryngeal mask withdrawal;measure the cuff pressure and sealing pressure of the laryngeal mask;observe and record the flexible visual scope at the opening of the laryngeal mask and the display screen of the visual laryngeal mask.The glottal exposure grade under the following test;the occurrence of postoperative complications was recorded.Results:A total of 74 preschool children with Microtia were recruited,4 were excluded,and the last 70 children were included in the analysis.All 70 children completed the insertion of the laryngeal mask,and completed the endotracheal intubation and withdrawal of the laryngeal mask under the video of the laryngeal mask.The visible laryngeal mask insertion time,endotracheal intubation time and laryngeal mask withdrawal time were(18.3±11.6)s,(35.1±20.9)s and(30.2 ±9.3)s respectively;the laryngeal mask was successfully inserted once.Among the 61 cases,8 cases and 1 case were successfully placed in the second and third times respectively(both are No.3 laryngeal masks).7 children needed to tilt their head back and help the assistant to support the mandible when the laryngeal mask was inserted;all children completed the tracheal intubation under the direct vision of the SaCoVLM visual laryngeal mask,of which 18 cases(25.7%)were directly intubated,36 cases(51.4%)intubated after inflating the laryngeal mask with 10-20ml or rotating the endotracheal tube counterclockwise,and 16 cases(22.9%)required combined inflation and reverse rotation of the endotracheal tube to complete intubation,There was 1 case of endotracheal tube prolapse when withdrawing the tube.The direct vision rate of the glottis under the flexible scope at the opening of the laryngeal mask was 90%.The average leak pressure and average cuff pressure of the laryngeal mask were(26.7±5.5)cmmH2O and(46.8±21.2)cmH2O,respectively.After the laryngeal mask was removed,15 cases had blood on the tip(both were No,3 laryngeal masks),and 16 cases had blood on the back side.Two cases of children who applied No.3 laryngeal masks had obvious sore throat(grade 2 throat pain),and no special treatment was given,spontaneous recovery without hoarseness and tooth damage.Part 2:Comparison of the video laryngeal mask airway SaCoVLM-guided tracheal intubation and the Air-Q combined with flexible intubation scope guided intubation in general anesthetized children with ear deformitiesMethods:120 children scheduled for ear reconstruction surgery under general anesthesia were randomly divided into Air-Q laryngeal mask group(group A)and SaCoVLM laryngeal mask group(group S).After the laryngeal mask was placed in place,Endotracheal intubation was performed with flexible visual endoscopy and SaCoVLM laryngeal mask.The time for successful tracheal intubation was primarily assessed.The ease,time,and number of attempts for successful device insertion,leak pressures,cuff pressures,fiberoptic grade of laryngeal view,glottal exposure classification on SaCoVLM laryngeal mask display screen,number of attempts,time for removal of the device after tracheal intubation,and complications were secondarily assessed.Results:A total of 128 patients undergoing ear deformity revision surgery under general anesthesia endotracheal intubation were evaluated and evaluated,8 patients were excluded,and finally 120 patients were included in the analysis.Device placement,tracheal intubation,and removal after tracheal intubation were successful in all patients.The laryngeal mask insertion time,tracheal intubation time and laryngeal mask withdrawal time of group A and S were(14.1 ±7.2)sand(19.5± 12.2)s,respectively(P<0.05),(39.8±9.5)s and(32.4± 17,1)s(P<0.05),(18.4±5.1)s and(30.7±8.6)s(P<0.05);There were no differences in flexible visual endoscopy grade of view between devices and the percentage of glottis seen was 90.0%(Group A)vs 88.3%(Group S)respectively;the average leakage pressure and the average cuff pressure of group A and S are(20.4±4.8)cm H2O and(26.0±5.2)cmH2O(P<0.05),(23.3± 11.3)cm H2O and(47.4±21.9)cm H2O(P<0.05).There was no difference in the postoperative complications of the two intubation methods,each case had bronchospasm,which improved after deepening anesthesia,and the blood carrying rate in group S after removal of the laryngeal mask was 33%higher than that in group A(P<0.05).Part 3:A novel technique for insertion of SaCoVLMTM laryngeal mask airway:Comparison of the stylet tool with the standard method insertion in children with ear deformities,a prospective,randomised studyMethods:Patients who underwent general anesthesia for external ear reconstruction were randomly divided into the SaCoVLM laryngeal mask group(C group)and the plastic stylet laryngeal mask group(S group).The C group slowly inserted the SaCoVLM visual laryngeal mask into the pharynx,and then connected the anesthetic machine to the manual ventilation after the insertion was in place.The S group needed to insert the guide tube of the tracheal intubation into the gastric suction channel of the visual laryngeal mask,and the tip should not exceed the outlet of the channel.Then the laryngeal mask airway was connected to the sleeve chain and folded into an angle of nearly 90 degrees.The tip of the laryngeal mask sleeve was raised to about 30 degrees,and the remaining technique was the same as the C group.Main observation indicators:diffculty of laryngeal mask insertion;Secondary observation indicators:recording the insertion time of SaCoVLM visual laryngeal mask,tracheal intubation time and SaCoVLM visual laryngeal mask removal time;Recording the adjustment and number of SaCoVLM visual laryngeal mask insertion,and the situation of changing the position of the guide tube tip by rotating the tracheal intubation;Measuring the sleeve pressure and laryngeal mask seal pressure of SaCoVLM visual laryngeal mask;Observing and recording the vocal cords and epiglottis seen under the direct vision of the visual intubation endoscope,and grading the bleeding sites(back tip or front)after the SaCoVLM visual laryngeal mask was removed,and the postoperative two hours pharynx and larynx pain intensity,hoarseness and other complications.Injury indicators:Immediately after intubation,the laryngeal and pharyngeal mucosal damage was observed under the visual intubation endoscope.Results:A total of 115 patients undergoing external ear reconstruction surgery under general anesthesia tracheal intubation were evaluated and 5 patients were excluded,and a total of 110 patients were enrolled in the study,55 in the C group and 55 in the S group.49 cases(89.1%)in the C group were successfully inserted once,and 52 cases(94.5%)in the S group were successfully inserted once,without statistical difference between the two groups.The laryngeal mask insertion difficulty score in the two groups,26 cases(47.3%)in the C group,45 cases(81.8%)in the S group,23 cases(41.8%)in the C group,10 cases(18.2%)in the S group,6 cases(10.9%)in the C group and 0 cases(0%)in the S group,the difference was statistically significant(p=0.00).There was no statistical difference in the leakage pressure of the laryngeal mask,the insertion time of the laryngeal mask,the intubation time,the withdrawal time of the laryngeal mask,the intubation maintenance time and the vocal cord score under the visual intubation endoscope.The incidence of bleeding after the laryngeal mask was removed was 43.6%in the C group and 25.5%in the S group,which was significantly lower than that in the C group(p=0.008).The incidence rate of group C with an injury score of 0 was 20%,and the incidence rate of group S was 56.4%,which was significantly higher than that of group C.Among them,the incidence rate of group C with an injury score of 3 was 49.1%,and the incidence rate of group S was 25.5%,which was significantly lower(p=0.001).Conclusions:1.Children with ear deformity can easily complete tracheal intubation under direct vision of SaCoVLM visual laryngeal mask,which is simple to operate and has a high success rate,and does not require the use of visual endoscope guidance.2.Children with ear deformity can complete tracheal intubation through SaCoVLM visual laryngeal mask and Air-Q intubation laryngeal mask,tracheal intubation through SaCoVLM visual laryngeal mask can avoid the use of visual endoscope and significantly shorten the intubation time,while Air-Q intubation laryngeal mask is easier to insert and remove.3.Using a plastic tube core to adjust the curvature of the front end of the laryngeal mask can reduce the difficulty of laryngeal mask insertion;The plastic core shaping method can reduce the immediate damage to the oral and pharyngeal mucosa caused by the operation technique.