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Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 14  |  Issue : 4  |  Page : 627-631  

Assessment of success and ease of insertion of proseal™ laryngeal mask airway versus I-gel™ insertion by paramedics in simulated difficult airway using cervical collar in different positions in manikins


1 Department of Anaesthesiology, VMMC and Safdarjang Hospital, New Delhi, India
2 Department of Emergency Medicine, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India
3 Department of Anaesthesiology, Shri Venkateshwara Hospital, Delhi, India

Date of Submission27-Jul-2020
Date of Decision06-Aug-2020
Date of Acceptance13-Aug-2020
Date of Web Publication06-May-2021

Correspondence Address:
Dr. Ankita Kabi
Department of Emergency Medicine, All India Institute of Medical Sciences, Virbhadra Marg, Rishikesh - 249 203, Uttarakhand
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/aer.AER_72_20

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   Abstract 

Background: Tracheal intubation, a critical intervention, performed by paramedics for airway management in trauma, has an unacceptably low success rate due to difficult airway, restricted access, and inexperience. Thus, the use of supraglottic devices to achieve ventilation has gained popularity. Aims: We aimed to compare the success rate, time to achieve ventilation, and ease of insertion of two popular supraglottic devices, ProSeal™ laryngeal mask airway (PLMA) and I-gel™, in simulated difficult airway with limited access in manikins in different positions which were supine, head against the wall, and sitting position like in car seat. Settings and Design: This was a prospective interventional study. Materials and Methods: After a brief training, 35 paramedics were asked to insert I-gel™ and PLMA in a manikin with cervical collar in 3 positions: head end free (Group A), head against the wall (Group B), and sitting position (Group C), to simulate difficult airway. Success rate and time to achieve ventilation in each position were noted. Each participant graded ease of insertion. Statistical Analysis: Statistical analysis was performed using SPSS 24.0. Categorical variables were analyzed using a Pearson's Chi-square test. Continuous variables were analyzed using the Kolmogorov–Smirnov test. If there was a normal distribution, a paired t-test was performed. Otherwise, a Wilcoxon signed-rank test was performed. P < 0.05 was considered statistically significant. Results: Success rate with I-gel™ was significantly higher than PLMA, 91% versus 77% in Group A, 100% versus 88% in Group B, and 100% versus 74% in Group C. Time to achieve ventilation was shorter with I-gel™ than PLMA, 8.9 versus 15 s in Group A (P < 0.001), 13.1 versus 21.3 s in Group B (P < 0.01), and 18.5 versus 30.3 s in Group C (P < 0.001). Conclusion: I-gel™ can be an effective device to achieve ventilation in difficult airway with limited access in trauma. More studies are required to validate its success and safety.

Keywords: Airway, difficult access, I-gel™, Paramedics, ProSeal™ LMA


How to cite this article:
Gupta A, Kabi A, Gaur D. Assessment of success and ease of insertion of proseal™ laryngeal mask airway versus I-gel™ insertion by paramedics in simulated difficult airway using cervical collar in different positions in manikins. Anesth Essays Res 2020;14:627-31

How to cite this URL:
Gupta A, Kabi A, Gaur D. Assessment of success and ease of insertion of proseal™ laryngeal mask airway versus I-gel™ insertion by paramedics in simulated difficult airway using cervical collar in different positions in manikins. Anesth Essays Res [serial online] 2020 [cited 2021 Jun 17];14:627-31. Available from: https://www.aeronline.org/text.asp?2020/14/4/627/315525


   Introduction Top


Paramedics or the emergency trauma technicians (EMTs) are the people who have completed a course and received certification in providing prehospital care for medical emergencies. They are the first responders worldwide to arrive and assist at the scene of an emergency like accident, natural disasters, and terrorist attacks. As per Advanced Trauma Life Support (ATLS), airway is the greatest threat to life and needs to be secured first with cervical spine immobilization.[1] According to the European Resuscitation Council guidelines, the most definitive management is endotracheal intubation at present.[2] In actual clinical setting, however, the frequency of its use has been reported to be very low.[3] Various types of alternative equipment such as supraglottic airway device (SGD) have been developed through continuous researches,[3],[4] to buy time till definitive airway is established.

Laryngeal mask airway (LMA) is a SGD that is most frequently used. Even nonexperienced users can operate it because the technique of its use can be easily acquired.[5]

ProSeal™ LMA (PLMA; Intavent Orthofix, Maidenhead, UK) is an improvement on the classic LMA (cLMA) for controlled ventilation. The introducer enables insertion without placing a finger in the patient's mouth. A correctly positioned PLMA separates the gastrointestinal and respiratory tracts, which increases protection against aspiration of gastric contents. The PLMA offers an airway that bridges some of the gaps between the cLMA and the endotracheal tube.[6]

I-gel™ (I-gel™, Intersurgical, Wokingham, UK) is a SGD that has been developed more recently so that the user can easily acquire the technique of use and can promptly manage the airway.[7]

At the scene of real-life trauma situation, the paramedics can be faced with patients in different adverse positions. As per ATLS in a trauma scenario, it is imperative to consider trauma to the cervical spine and stabilize it using a collar when handling a patient or transporting a patient until proved otherwise. Hence, we have tried to simulate a similar situation to assess the preparedness and level of confidence in securing the airway by the paramedics.

It is difficult and unethical to carry out the study in real-life scenario and so we conducted the study in manikins with simulated difficult airway using cervical collar with the manikin in different positions that were supine, head against the wall, and sitting position as in a car accident. The paramedics inserted the SGD from the head end in the supine position. In the other two positions of the manikin, the paramedics inserted the SGD from the front and right side of the manikin. The aim of this study was to assess the success rate and time taken for successful insertion and ventilation by PLMA and I-gel™ by paramedics in manikins with simulated difficult airway in different positions. The secondary objective is to assess the ease of insertion and preferences of the paramedics between the two devices.


   Materials and Methods Top


The study was conducted as an educational course at the Department of Anesthesiology in VMMC and Safdarjung Hospital.

Ethical statement

The study was approved by the Institutional Ethics Committee of V.M.M.C and Safdarjung Hospital, New Delhi 110029 (Approval no. IEC/VMMC/SJH/Project/February/2016/558) dated on 04/03/2016. The study procedure follows the guidelines laid down in Declaration of Helsinki (2013).

Study design

This was a prospective study. After taking approval from the Hospital Ethics Committee, informed consent was obtained from each participant before conducting the following crossover study.

Subjects

Thirty-five paramedical students were enrolled. A qualified anesthesiologist/instructor conducted the educational course, which was composed of a 30-min interactive class and a 60-min exercise.

In the interactive session, the paramedics were taught to check, prepare, and insert the device, followed by attaching it to AMBU and successfully ventilating the manikin. It was ensured that each paramedic successfully inserts and ventilates through each SGD at least 5 times with and without the cervical collar. The manikins used were two Laerdal advanced airway trainers. The SGDs used were size 4 ProSeal™ LMA and size 4 I-gel™.

Following this 60-min exercise, the participants underwent performance assessment on using the two devices in simulated difficult airway using a cervical collar with the manikin placed supine, supine with the head against the wall, and sitting position as in a car seat, entrapment scenario. Therefore, in the simulation, three scenarios for each SGD were created. A total of six scenarios were designed.

Group A – The manikin was placed supine with head end free and ventilated with PLMA and I-gel™, with the paramedic standing at the head end.

Group B – The manikin was placed with the head against the wall and ventilated with PLMA and I-gel™, with the paramedic standing in front and to the right of the manikin.

Group C – The manikin was placed in sitting position as in a car seat and ventilated with PLMA and I-gel™, with the paramedic standing in front and to the right of the manikin.

The instructor noted whether the SGD was being properly inserted and that the manikin was getting adequately ventilated and also measured the time lapse from holding of the device to the end point of adequate chest rise.

A feedback form was used to measure the ease of insertion and preference about each device in simulated difficult airway in different positions of manikins on a Likert five-point scale with a range from 1 (very poor) to 5 (very good).

Statistical analysis

The data were entered in MS Excel spreadsheet. Statistical analysis was performed using SPSS statistics for Macintosh version 24.0 manufactured by IBM Corp., Armonk, NY (USA). According to the characteristics of each variable, continuous variables were expressed using mean, standard deviation, median value, and interquartile range. Categorical variables were analyzed using a Pearson's Chi-square test. Continuous variables were analyzed using the Kolmogorov–Smirnov test in order to verify the normal distribution. If there was a normal distribution, a paired t-test was performed. Otherwise, a Wilcoxon signed-rank test was performed. P ≤ 0.05 was considered statistically significant.


   Results Top


In the study, the participants were all novice EMTs who completed 1 year of training in our institute recently. The group included 20 boys and 15 girls. The mean age of participants was 20 years. Each participant was his own control while evaluating the two SGDs.

In Group A, with manikin head end free and cervical collar, PLMA was successfully inserted by 27 (77.1%) candidates and I-gel™ was successfully placed by 32 (91.4%) candidates, with the statistical difference being significant (P < 0.01) [Table 1] and [Figure 1]. The mean time for successful insertion and ventilation in Group A for PLMA was 15 (3.4) s and for the I-gel™ group was 8.9 (2.4) s, and the statistical difference between the mean of these two groups (P < 0.001) was statistically significant [Table 2] and [Figure 2].
Table 1: Comparison of success rate in percentage of insertion of supraglottic airway device in the first attempt

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Figure 1: Success rate of insertion of supraglottic airway devices in different positions of manikin

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Table 2: Comparison of insertion time between ProSeal™ laryngeal mask airway and I-gel™ in positions A, B, and C

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Figure 2: The mean insertion time in seconds of the supraglottic airway devices in different positions of manikin

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In Group B, with the manikin's head against the wall, success of insertion and ventilation in the PLMA group was 88.6% (31 out of 35), and in the I-gel™ group, it was 100%, the difference being statistically significant (P < 0.01) [Table 1] and [Figure 1]. The mean time for successful insertion and ventilation in the PLMA group was 21.3 (3.9) s, while in the I-gel™ group, it was 13.1 (3.7) s. On comparison, the difference between the mean time for both the groups (P < 0.001) was statistically significant [Table 2] and [Figure 2].

In Group C, with the manikin in sitting position, success of insertion and ventilation in the PLMA group was 74.3% (26 out of 35), with a mean time recorded as 30.3 (3.6) s. Success of insertion and ventilation in the I-gel™ group was 100%, with a mean time of 18.5 (3.4) s. The difference in success rate and mean time of successful insertion and ventilation was statistically significant (P < 0.001) [Table 1],[Table 2] and [Figure 1], [Figure 2].

The ease of insertion in all the groups with I-gel™ was significantly higher than the PLMA group, especially in Group C, the sitting position, whereby the ease of insertion of PLMA had a median value of 2 compared to a median value of 4 in the I-gel™ group. Thirty-four out of 35 (97.4%) paramedics said that they would prefer to use I-gel™ as compared to PLMA in a difficult airway with limited access [Table 3] and [Figure 3].
Table 3: Response on self-assessment for the perceived ease of insertion of supraglottic airway device in positions A, B, and C

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Figure 3: The perceived ease of insertion of the supraglottic airway devices in different positions of manikin according to the self-assessment form using Likert scale (1–5)

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   Discussion Top


There are studies in literature comparing the clinical performance and use of PLMA and I-gel in emergency medicine, the two popularly used SGDs, and however, to the best of our knowledge, our study is the first study comparing their success rate and time to ventilation in difficult airway scenario with difficult and restricted access by paramedics only.

Endotracheal intubation is the gold standard for securing airway in trauma to prevent hypoxia and obstruction of airway. Securing airway in an emergency out of hospital setting is very challenging as compared to controlled hospital settings. As reported by Hulme et al. that due to restricted access in trauma scenarios, the rate of failed intubations is much higher.[8] Deakin et al. reported that even under optimal conditions, in hospital and anesthetized patients, 30% of attempts at intubation by paramedics were unsuccessful, while only 12% of attempts at LMAs were unsuccessful.[9] Paramedics are the first responders in trauma, and failure of intubation is high due to restricted access, presence of cervical collar, and level of expertise and training required as compared to anesthesiologists. SGDs have a comparatively lower failure rate than tracheal intubation; hence, ATLS guidelines and Advanced Cardiac Life Support (ACLS) guidelines have included the use of SGD for airway management in case of failure to intubation and difficult airway.[1],[10]

It is difficult to conduct a real-time trauma study; hence, a manikin study was conducted simulating difficult airway using cervical collar. In a clinical setting, access to the airway can be very challenging; hence, difficult access scenarios such as head against the wall and sitting position were simulated.

Martin et al. conducted a manikin study to compare airway management methods in entrapped patients and concluded that blindly placed device (laryngeal tube) may provide better avenues for airway management than conventional direct laryngoscopy and intubation.[11] Wetsch et al. too corroborated that the first ventilation was achieved significantly faster with a much higher success rate with SGD than tracheal intubation in entrapment scenario in a manikin study.[12] However, no guidelines exist regarding which SGD should be used by paramedics in difficult entrapment scenarios and when they fail to intubate by conventional methods. There are manikin studies comparing I-gel™ with video laryngoscope for tracheal intubation in trauma and entrapment scenario, but the role of video laryngoscope in trauma is debatable due to obscuring of vision by blood.[13] The choice of SGD in trauma is left to the comfort and experience of the paramedic.

Our study points out that I-gel™, as compared to PLMA, has a significantly better success rate at securing the airway in all the three positions described. The time taken for achieving ventilation is significantly lower in the I-gel™ group as compared to PLMA, which could possibly be attributed to the fact that no cuff inflation is required for the placement of I-gel™. In accordance with previous studies evaluating SGDs on airway manikins, we found I-gel™ to be superior regarding ease of handling and time of insertion.[14],[15] Furthermore, the excellent performance of the I-gel™ in clinical and emergency settings is well documented.[16],[17],[18],[19]

Our results corroborate with Kwak et al., who compared cLMA with I-gel™ in a manikin study by inexperienced users and nurses and found that airway control was much faster with latter than former in normal (28.3 ± 8.3 vs. 10.0 ± 3.7 s) and simulated difficult airway (29.1 ± 8.2 vs. 10.3 ± 3.0 s) using a cervical collar.[20] Their study also concluded that I-gel™ had a higher positive response for attitude and preference as compared to cLMA. Gartward et al. compared the time lapse of airway management through endotracheal intubation, cLMA, PLMA, and I-gel™ in manikins, which was 15.9 s, 14.6 s, 14.0 s, and 7.0 s, respectively.[21] Our study echoes with the above two mentioned studies, but they did not compare the insertion of PLMA and I-gel™ in difficult access scenario like head against the wall or entrapment.

Park et al. in the systemic review and meta-analysis, comparing I-gel™ and PLMA during general anesthesia, concluded that both devices were comparable in ease of insertion and rate of successful intubation in anesthetized adults.[22] In contrast, our study has a higher success rate for insertion and subsequent successful ventilation in the I-gel™ group than PLMA that can probably be attributed to the fact that we had simulated a difficult airway with limited access as compared to normal airway.

Stromplius et al. conducted a manikin study, where they compared success rate and time for insertion between I-gel™ and cLMA.[23] They concluded that I-gel™ significantly improved success rates and insertion time compared with cLMA. Most importantly, I-gel™ use resulted in high first-pass success rates for novice doctors, equal to those achieved by experienced doctors (91% vs. 90%, P = not significant). Our study corroborates with their findings that I-gel™ has a better and faster success rate at achieving ventilation as compared to not only first-generation SGD like cLMA but also second-generation SGD like PLMA, which is an improved version of the first-generation SGD.

However, our study has a few limitations. It is a manikin study, and real-time difficulties of a trauma scenario and difficult airway cannot be extrapolated. We simulated difficult airway using a cervical collar and restricting access, but anatomical variations may play an important role in actual clinical setting. Moreover, since the subjects are not humans, we could not compare the complications associated with these SGDs. Our sample size was relatively small with limited clinical experience. With more work experience and knowledge of the study participants, the comfort and speed of securing airway using the airway devices may vary. A real-time study or a retrospective analysis of the experiences of paramedics with different SGDs will provide a better guide as to how to deal with difficult airway with limited access in trauma.


   Conclusion Top


In the current study, after conducting an educational and practice session with paramedics, we evaluated the success rate and time for achieving successful ventilation by PLMA and I-gel™ in difficult airway scenarios with manikins in different positions. We found that I-gel™ as compared to PLMA can achieve ventilation faster with a higher success rate in simulated difficult airway scenarios. I-gel™ can be a very valuable asset in the field of trauma, but more real-time studies would be required to assess its advantages, safety, and disadvantages if any over other SGDs.

Declaration of participant consent

In the form, the participant has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The participants understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

1.
ATLS Subcommittee, American College of Surgeons' Committee on Trauma, International ATLS working group. Advanced trauma life support (ATLS®): The ninth edition. J Trauma Acute Care Surg 2013;74:1363-6.  Back to cited text no. 1
    
2.
Deakin CD, Nolan JP, Soar J, Sunde K, Koster RW, Smith GB, et al. European Resuscitation Council Guidelines for Resuscitation 2010 Section 4. Adult advanced life support [published correction appears in Resuscitation 2011;82:140]. Resuscitation 2010;81:1305-52.  Back to cited text no. 2
    
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Eun SJ, Kim H, Jung KY, Cho KH, Kim Y. Prospective multicenter evaluation of prehospital care by 119 rescues ervices. J Korean Soc Emerg Med 2007;18:177-89.  Back to cited text no. 3
    
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Wang HE, Mann NC, Mears G, Jacobson K, Yealy DM. Out-of-hospital airway management in the United States. Resuscitation 2011;82:378-85.  Back to cited text no. 4
    
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Steel A. The intubating laryngeal mask airway. Emerg Med J 2005;22:47-9.  Back to cited text no. 5
    
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Cook TM, Lee G, Nolan JP. The ProSeal™ laryngeal mask airway: A review of the literature. Can J Anesth 2005;52:739-60.  Back to cited text no. 6
    
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Hulme J, Perkins GD. Critically injured patients, inaccessible airways, and laryngeal mask airways. Emerg Med J 2005;22:742-4.  Back to cited text no. 8
    
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Deakin, CD, King P, Thompson F. Prehospital advanced airway management by ambulance technicians and paramedics: Is clinical practice sufficient to maintain skills? Emerg Med J 2009;26:888-91.  Back to cited text no. 9
    
10.
Soar J, Maconochie I, Wyckoff MH, Olasveengen TM, Singletary EM, Greif R, et al. 2019 International consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations: Summary from the basic life support; advanced life support; pediatric life support; neonatal life support; education, implementation, and teams; and first aid task forces. Circulation 2019;140:e826-80.  Back to cited text no. 10
    
11.
Martin AB, Lingg J, Lubin JS. Comparison of airway management methods in entrapped patients: A manikin study. Prehosp Emerg Care 2016;20:657-61.  Back to cited text no. 11
    
12.
Wetsch WA, Schneider A, Schier R, Spelten O, Hellmich M, Hinkelbein J. In a difficult access scenario, supraglottic airway devices improve success and time to ventilation. Eur J Emerg Med 2015;22:374-6.  Back to cited text no. 12
    
13.
Wetsch WA, Spelten O, Hellmich M, Carlitscheck M, Padosch SA, Lier H, et al. Comparison of different video laryngoscopes for emergency intubation in a standardized airway manikin with immobilized cervical spine by experienced anaesthetists. A randomized, controlled crossover trial. Resuscitation 2012;83:740-5.  Back to cited text no. 13
    
14.
An J, Nam SB, Lee JS, Lee J, Yoo H, Lee HM, et al. Comparison of the i-gel and other supraglottic airways in adult manikin studies: Systematic review and meta-analysis. Medicine (Baltimore) 2017;96:e5801.  Back to cited text no. 14
    
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Gatward JJ, Cook TM, Seller C, Handel J, Simpson T, Vanek V, et al. Evaluation of the size 4 i-gel airway in one hundred non-paralysed patients. Anaesthesia 2008;63:1124-30.  Back to cited text no. 16
    
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Choi GJ, Kang H, Baek CW, Jung YH, Woo YC, Cha YJ. A systematic review and meta-analysis of the i-gel® vs. laryngeal mask airway in children. Anaesthesia 2014;69:1258-65.  Back to cited text no. 17
    
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Lai CJ, Liu CM, Wu CY, Tsai FF, Tseng PH, Fan SZ. I-gel is a suitable alternative to endotracheal tubes in the laparoscopic pneumoperitoneum and trendelenburg position. BMC Anesthesiol 2017;17:3.  Back to cited text no. 18
    
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20.
Kwak DI, Yoo JH, No HW, Sohn JD, Kim YJ, Nah JH. Comparison between the LMA Classic and new I-gel supraglottic airway device: A manikin study. Hong Kong J Emerg Med 2013;20:25.  Back to cited text no. 20
    
21.
Gatward JJ, Thomas MJ, Nolan JP, Cook TM. Effect of chest compressions on the time taken to insert airway devices in a manikin. Br J Anaesth 2008;100:351-6.  Back to cited text no. 21
    
22.
Park SK, Choi GJ, Choi YS, Ahn EJ, Kang H. Comparison of the i-gel and the laryngeal mask airway proseal during general anesthesia: A systematic review and meta-analysis. PLoS ONE 2015;10:e0119469.  Back to cited text no. 22
    
23.
Stroumpoulis K, Isaia C, Bassiakou E, Pantazopoulos I, Troupis G, Mazarakis A, et al. A comparison of the i-gel and classic LMA insertion in manikins by experienced and novice physicians. Eur J Emerg Med 2012;19:24-7.  Back to cited text no. 23
    


    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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