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. Author manuscript; available in PMC: 2022 Jan 1.
Published in final edited form as: Emerg Med J. 2020 Oct 12;38(1):27–32. doi: 10.1136/emermed-2020-209929

Cluster crossover randomized trial of pediatric airway management devices in the simulation lab and operating room among paramedic students

Matt Hansen 1, Adam Wagner 2, Ashley Schnapp 3, Amber Lin 1, Nancy Le 1, Sarah Deverman 4, Elizabeth Pedigo 4, Andrea Johnson 4, Jordan Cusick 4, Heike Gries 4, Meredith Kato 4
PMCID: PMC8064274  NIHMSID: NIHMS1683970  PMID: 33046528

Abstract

Objectives:

The objective of this study was to compare pediatric emergency airway management strategies in the simulation lab and operating room environments.

Methods:

This was a two-part cluster crossover randomized trial including simulation lab and operating room environments conducted between January 2017 and June 2018 in Portland, Oregon, USA. In simulated infant cardiac arrests, paramedic students placed an endotracheal tube, an i-gel®, or a laryngeal mask airway in random order. In the operating room, paramedic students placed a laryngeal mask airway or i-gel® device in random order in sequential patients. The primary outcome for both portions of the study was time to ventilation. In the operating room portion, we also evaluated leak pressures and average initial tidal volumes.

Results:

There were 58 paramedic students who participated in the simulation lab and 22 who participated in the operating room study. The mean time to airway placement in the simulation lab was 48.5 seconds for the i-gel®, 68.9 seconds for the laryngeal mask, and 129.5 seconds for the endotracheal tube. In the operating room, mean time to i-gel® placement was 34.3 seconds with 45.2 seconds for the laryngeal mask. In multivariable analysis of the simulation study, the laryngeal mask and i-gel® were significantly faster than the endotracheal tube, and the i-gel® was faster than the laryngeal mask. In the operating room, there was no significant difference in time to placement, leak pressure, and average volume of the first 5 breaths between the i-gel® and laryngeal mask.

Conclusions:

We found that paramedic students were able to place supraglottic devices rapidly with high success rates in simulation lab and operating room environments. Supraglottic devices, particularly the i-gel, were rated as easy to use. The i-gel may be easiest to use since it lacks an inflable cuff and requires fewer steps to place.

Keywords: laryngeal masks, airway management, intubation, endotracheal, Emergency Medical Technicians

Introduction

Pediatric airway management is a rarely performed yet critical skill for prehospital emergency medical systems (EMS).1 A previous randomized trial on paediatric airway management in EMS, conducted prior to the availability of supraglottic devices (SGA), found no difference in patient outcomes between bag valve mask ventilation and endotracheal intubation (ETI), with trends towards harm in certain patient subgroups treated with ETI.2 Despite this study, ETI remains the dominant pediatric airway management practice in EMS in the United States.1,3 However, in selected US states and EMS agencies, as well as many areas of the United Kingdom, paramedics do not perform pediatric ETI and rely on supraglottic airways and/or bag-valve-mask ventilation.4,5 Recently, supraglottic devices have become increasingly common in EMS, especially in the setting of adult cardiac arrest.68 These devices generally require less training, are potentially faster to use, and can ventilate as well as an endotracheal tube.9,10 These studies may result in fewer intubations being performed in EMS and increased use of supraglottic airways. However, we were unable to identify any studies describing success rates of paramedics inserting supraglottic devices in children.

There are several supraglottic airways that could be used in children in EMS.11 Laryngeal mask airways that have an inflatable cuff are used in both children and adults in operating rooms worldwide.12 However, it appears that these types of laryngeal masks have lower success rates than in the operating room when used in prehospital care among adults, though there is limited clinical data.1,13,14 The i-gel® (Intersurgical, Workingham, Berkshire, UK) is another supraglottic airway device that is similar to the laryngeal mask, but does not have an inflatable cuff. The i-gel® has been studied in the operating room in pediatric patients and has generally found to be comparable to laryngeal mask devices.1518 In this paper, we will refer to the broad category of laryngeal mask airways with inflatable cuffs as “laryngeal mask airways” while referring to the i-gel®, distinguished by a non-inflatable cuff by its trade name.

There is limited published data regarding the use of supraglottic devices in children in the prehospital environment despite emerging widespread use.19 The objective of this study was to compare the relative speed of insertion and ease of use of the i-gel® and laryngeal mask airways among paramedic students, first in the simulation lab and then in operating room environments. Our primary hypotheses were that all supraglottic devices would be more rapid to insert than an endotracheal tube and would be easy to place with minimal training.

Methods

Overall Study Design

This was a cluster crossover randomized trial with two phases, one in the simulation lab and another in the operating room. The simulation lab portion of the study took place between three and six months before the operating room portion. The two phases were planned to mimic the training and deployment of a supraglottic device in an EMS agency, where training is usually conducted using basic mannequin simulation, and then the device is deployed in the field, often after a significant length of time has passed since training. The design of the study allowed us to determine if the simulation training would translate into success in real patients. Since paediatric advanced airways are rare in practice, and the environment is uncontrolled, for the deployment phase, we used the operating room, which allowed us to make more precise measurements using human subjects.

Study Design-Simulation Lab

Simulations were conducted using two infant mannequins (Laerdal Sim NewB, Gaummard Newborn Hal) at a paramedic school simulation center and university hospital simulation center. The student participants used an EMS equipment bag that is standard for one of the large local EMS agencies and was packed the same way for each scenario. The three devices used in the study were the i-gel®, the Ambu® AuraGain™ laryngeal mask (Ambu, Columbia .MD), and a cuffed endotracheal tube (using a stylette). Participants were instructed to use the Miller 1 laryngoscope blade from the airway kit in the equipment bag and were oriented in advance to the airway devices, simulators, and location of the equipment in the bag.

The study subjects were paramedic students who had not completed the Pediatric Advanced Life Support (PALS) course. The scenario was described as an unresponsive pulseless infant. Participants responded to the scenarios in pairs and started the scenario at a standardized distance from the simulator. They were instructed that one person would perform CPR and the other would perform airway management using the device indicated by the randomization scheme. We instructed them to not perform vascular access, medications, rhythm analysis, or other aspects of PALS and to focus on airway management and CPR.

Each participant was the airway operator three times, once for each device. The two participants in the team alternated turns as the airway operator. The order of devices was randomized for each participant using the online tool at randomizer.org. The primary outcome was time from initiation of the scenario to successful ventilation through the airway device with a self-inflating bag, which was recorded in real-time during the scenario. The stopwatch started when the participants entered the room and was stopped when first breath was delivered through the device. After the simulation scenarios, students completed a survey regarding the ease of use of all of the study devices. The secondary outcome was ease of use of each device. Based on a previous study, we estimated we had 80% power to detect a 23 second difference in time to ventilation (mean 46 [SD 32] versus 23 [SD 21] seconds) between ETI and a supraglottic device with 33 participants using a paired t-test.20 There were insufficient preliminary data to calculate power for analyses comparing the i-gel® to the LMA.

Study Design-Operating Room

A convenience sample of paramedic students that had completed the simulation portion of the study were recruited for this second phase of the study. The air-Q® is the standard laryngeal mask in this hospital. Each student placed an i-gel® and an air-Q®(Cookgas, St Louis, MO), in separate consecutive patients, and the order of device placement was randomized using the online tool at randomizer.org. Eligible patients were <18 years and had a procedure where a supraglottic device was planned by the attending pediatric anesthesiologist. A research team member enrolled all patients and assigned them to the specific study intervention based on the randomization scheme immediately after consent.

The primary outcome for this portion of the study was the time from cessation of mask ventilation to first end-tidal CO2 waveform on the anesthesia machine. Participants were not blinded to the outcome. Secondary outcomes included the leak pressure of the device (cm H2O) and average tidal volume (mL) of the first five breaths given through the airway device as indicated by the ventilator. Ventilator settings were determined by the attending anesthesiologist, but in all cases included a pressure support mode with 10–15 cm/H2O of inspiratory pressure and 5 cm/H20 of PEEP. A research team member was present in the operating room along with the student and recorded the outcomes in real-time. After the operating room cases, students completed a survey regarding the ease of use of the study devices. Based on data from a previous study, we estimated we would have 80% power to detect a 15 second difference (SD 20) using a paired t-test between devices with 22 participants.21 All analyses were completed using the assigned study arm except where otherwise specified.

The study was approved by the OHSU Institutional Review Board numbers 00016591 and 00016813. A study monitor was required to judge whether any adverse events were study related. The study sponsors did not have any role in the design, implementation, or interpretation of the study results. Verbal consent was obtained from all paramedic student participants. Written consent was obtained for all patients by parents or legal guardians.

Descriptive analysis

For the student participants in both the simulation and operating room portion of the study, we calculated descriptive statistics on sex, age, years of prior EMS experience, and presence of any previous healthcare degrees. As previous years of EMS experience was highly skewed, for the purpose of analysis, previous years was categorized into 4 categories of 0, 0-<3 years,3-<5 years, and 5+years. For the students in the operating room study, we further collected data on number of previous attempts in adults during their training (both in cadavers and the operating room), and hours of simulation training and lecture on supraglottic airway placements. We further collected and summarized patient age, presence of craniofacial dysmorphy and Mallampati score overall and by device. Outcomes were summarized via descriptive statistics using mean (SD) for continuous data and n (%) for categorical data. Descriptive statistics for ease of use were compared between the i-gel®, AuraGain®, and ETI in the simulation lab, and i-gel® and air-Q® in the operating room using the Wilcoxon signed-rank test.

Missing data

All missing data were imputed, and all available data were used in the multiple imputation model. IVEware, callable in SAS, was used for the imputation portion of the analysis. (IVEware, Survey Research Center, University of Michigan)

Multivariable analysis

For continuous outcomes, a linear mixed effects model with a random effect for student participant was used to account for the correlation between repeated measurements within student. We further included student characteristics to control for potential bias from including students with a large range of experience both in the field and with particular airway placements. For the analysis of time to insertion during the simulation lab, the primary predictor was type of airway and controlling variables included years of experience, gender, previous healthcare degree and student age. For the operating room portion analysis, outcomes included time to first breath, average volume of the first five breaths, and leak pressure. In addition to age, gender, years of prior EMS experience, and previous healthcare degree, in the final analysis we also controlled for number of i-gels® placed (in operating room or in cadaver lab) and number of laryngeal mask airways placed (any brand) in operating room or in cadaver lab by the individual student. Residual diagnostics and influence statistics were examined for all models.

All analyses were conducted in SAS 9.4 (Cary, NC). All tests were two-sided, and a statistical significance level of 0.05 was used for all tests.

Results

We enrolled 58 paramedic students in the simulation lab study and 22 students in the operating room study. Missing data for the simulation study included n=9 missing values for gender, age, and years of previous experience; n=1 value for previous number of ETIs and SGA placements; and n=1 post laryngeal mask assessment. Missing data for the operating room study including n=2 missing values for gender, age, years of previous experience, and one missing value for pressure. We did not lose any participants (students or patients) after randomization. Across both studies, participants were primarily males in the mid-twenties with less than 3 years of prior EMS experience and no previous healthcare degrees (Table 1). For participants in the operating room study, the average number of prior i-gel® placements was one and laryngeal mask airway placements was five. The average age of children in the operating room portion of the study was 4.6 years (SD 2.3). When stratified by study device, average patient age was similar [mean in i-gel® 4.6 (SD 2.1); mean age in AirQ® 4.6(2.5)]. Mallampati score was only able to be evaluated in 13 of the 42 pediatric participants due to age and ability to cooperate. Of the 13, three were class two and the remainder were class one. There was only one child with a potential congenital craniofacial problem (trisomy 21, laryngeal mask airway arm). Overall baseline patient characteristics were balanced between groups. (Table 2) There was one potential adverse event, clear material coming from the suction port of the i-gel® device, and it was not noted to be study related by the independent study monitor.

Table 1.

Paramedic Student Characteristics In Simulation Lab and Operation Room Study Phases

Student Characteristic Simulation n=58 (100%) Operating Room n=22 (100%)
Male gender, n(%) 29(59.2%) 12(60.0%)
Age, mean (SD) 27.1(7.4) 25.9 (7.1)
Years of prior EMS experience, n(%)
 None 9(18.4%) 4(20.0%)
 >0–3 years 20(40.8%) 12(60.0%)
 ≥ 3 years-<5 years 13(26.5%) 3(15.0%)
 5+ years 7(14.3%) 1(5.0%)
Previous health care degree, n(%) 2(3.5%) 0(0.0%)

Simulation: n=9 values missing for gender, age, years of previous experience; Operating Room: n=2 values missing gender, age, years of previous experience

Table 2.

Patient Characteristics in Operating Room Phase

i-gel® n=20 (48.8%) AirQ® n=21 (52.2%) Overall n=41 (100%)
Age, mean (SD) 4.6(2.1) 4.6(2.5) 4.6(2.3)
Craniofacial dysmorphy, n(%) 0(0.0%) 1(4.8%) 1(2.4%)
Mallampati Score
 Class 1 5(25%) 5(23.8%) 10(24.4%)
 Class 2 0(0%) 3(14.3%) 3(7.3%)
 Not Applicable 15(75%) 13(61.9%) 28(68.3%)

The unadjusted results for time to airway device placement in the simulation lab and operating room are displayed in Tables 3 and 4 and Figure 1. In the simulation lab, the i-gel® had the fastest unadjusted placement time as compared to both laryngeal mask and ETI. However, there were no significant differences in unadjusted time to airway placement between laryngeal mask and the i-gel® in the operating room analysis.

Table 3.

Results of airway type on time to success in the simulation lab

Unadjusted Analysis Mean (SD)
Airway
 i-gel® 48.5 s (20.6)
 AuraGain® 68.9 s (22.1)
 ETI 129.5 s (39.6)
Adjusted Analysis Mean Difference (95% CI)* p-value

Airway
 i-gel® −81.0 s (−89.5 to −72.5) <0.01
 AuraGain® −60.6 s (−69.1 to −52.1)
 ETI referent
Age (years) 0.2(−0.6 to 1.0) 0.65
Male gender 5.9(−6.7 to 18.5) 0.36
Years of prior EMS experience
 None referent 0.22
 >0–3 years 3.1(−13.3 to 19.4)
 ≥ 3 years-<5 years 8.5(−8.8 to 26.0)
 5+ years −8.6(−28.2 to 11.1)
Previous health care degree −17.7(−46.7 to 11.3) 0.23

S = seconds. Mixed effects model to control for repeated measurements within student and using methods to incorporate data from multiple imputed data.

Bolded italicized values are significant, p<0.05

*

difference in i-gel® and AuraGain® is as follows: As compared to AuraGain®, i-gel® shows a reduction in seconds of 20.4(95% CI:11.9 to 28.8, p<0.01).

Table 4.

Unadjusted statistics of time to success by airway type in the operating room

i-gel® AirQ®

n Mean (SD) n Mean (SD)
Operating room 21 34.3(15.4) 21 45.2(39.1)
Operating room (per protocol) 20 31.6(9.2) 20 45.2(39.1)

Figure 1.

Figure 1.

Box plots comparing time to airway placement in the simulation lab between endotracheal intubation (ETI), the i-gel®, and AuraGain®. The horizontal line within the box is the median, the diamond is the mean. The box contains the middle 50th percentile of observations. The whiskers represent last observation that is within 1.5 times the box height. The circles represent potential outliers.

In multivariable analysis of the simulation data, we found a significant reduction in time to ventilation for the i-gel® and AuraGain® as compared to ETI (p<0.01) (Table 3). The adjusted mean difference between the i-gel® and ETI was 81 seconds (95% CI: 72.5 to 89.5) and 60.6 (95% CI: 52.1 to 69.1) seconds for the AuraGain® versus ETI. Additionally, as compared to the AuraGain®, the i-gel® showed an adjusted reduction in 20.4 seconds in time to placement (95% CI: 11.9 to 28.8, p<0.01). There were no associations between placement time and age, gender, years of prior EMS experience or previous healthcare degree and model diagnostics indicated good model fit.

Of the 22 students in the operating room study, 21 performed both i-gel® and air-Q® placements on separate pediatric patients. In multivariate analysis of operating room data, there were no significant differences in time to the first breath, average volume of the first five breaths, and leak pressure between the i-gel® and the air-Q® when controlling for the study participant’s age, gender, years of experience, and previous number of airways placed (Table 5, Figure 2). Although not statistically significant, the average volume of the first five breaths was higher using the i-gel® as compared to the air-Q®, with a mean difference of 59.1 mL more volume per breath (95% CI: −5.5 to 123.6; p=0.07). Overall in the as-randomized analysis average leak pressure was 20.5 for the i-gel® and 18.6 for the laryngeal mask. Model diagnostics indicated good model fit for all outcomes, except time to the first breath, which identified one observation as an influential point. This observation was a priori defined as a protocol deviation, and the analysis was repeated without this datapoint. For the per-protocol analysis in which one i-gel® observation was removed due to a protocol deviation, as compared to the air-Q®, the i-gel had similar results, with the exception of a non-statistically significant mean difference of 3.7 (cm/H20) (95% CI −0.2 to 7.5; p=0.06) favouring the i-gel. Only one patient required more than one placement attempt to ventilate successfully. In this case, an air-Q® had to be replaced with a larger size and the replacement resulted in successful ventilation. Model diagnostics for the per-protocol analysis were all sufficient.

Table 5.

Results of regression of airway type on outcomes in the operating room

Time to first breath (seconds) Average tidal volume of first five breaths (mL) Leak Pressure cm/H20

Slope coefficient (95% CI)* p-value Slope coefficient (95% CI) p-value Slope coefficient (95% CI)* p-value
Airway
i-gel® −3.3(−21.9 to 15.3) 0.73 59.1(−5.5 to 123.6) 0.07 3.1(−0.6 to 6.9) 0.10
Air-Q® referent referent referent
Age −0.2(−1.4 to 1.1) 0.77 −0.6(−4.9 to 3.8) 0.80 0.2(−0.1 to 0.5) 0.12
Male gender 7.1(−14.8 to 29) 0.53 −30.3(−108 to 47.3) 0.44 3.9(−1 to 8.7) 0.12
Years of prior EMS experience
None referent 0.47 referent 0.38 referent 0.85
>0–3 years −10.9(−37.8 to 15.9) −2.9(−98.4 to 92.7) 0.9(−5.2 to 7)
3+ years −18.7(−48.3 to 10.8) 54.4(−50.5 to 159.2) −0.6(−7.2 to 6)
Number of previous placements of similar airway 2(−0.2 to 4.2) 0.07 2(−5.7 to 9.6) 0.62 −0.5(−1 to 0) 0.04

Mixed effects model to control for repeated measurements within paramedic student and using methods to incorporate data from multiple imputed data.

Bolded italicized values are significant, p<0.05

Findings, as compared to air-Q®, i-gel® showed a trend toward a higher average of the first five breaths with a mean differences of 59.1 mL (95% CI: −5.5 to 123.6; p=0.07). There was also a significant inverse relationship between number of previous placements and leak pressure with a decrease of 0.5 cm/H20 (95% CI: 0.0 to 1.0; p=0.04) (for each additional airway previously placed.

Figure 2.

Figure 2.

Box plots comparing time to airway placement in the operating room between the i-gel® and the air-Q®. The horizontal line within the box is the median, the diamond is the mean. The box contains the middle 50th percentile of observations. The whiskers represent last observation that is within 1.5 times the box height. The circles represent potential outliers.

Ease of use

Results for the ease of use ratings are presented in Table 6. In the simulation lab, 90% of participants rated the i-gel as one (easiest) to use on a 1–5 scale, while 17% of participants rated the laryngeal mask airway (Ambu®) as one, and 7% rated ETI as one. There were significant (p<0.01) differences in all pairwise comparisons: i-gel® vs laryngeal masks airway (sign rank S=495), laryngeal mask airway vs ETI (sign rank S=493), and i-gel® vs ETI (sign rank S=735). In the operating room, there was no difference in the distribution of ease of use between the i-gel® and air-Q® (with 73% of responses for i-gel® versus 52% for air-Q® of “easiest”; signed-rank test p-value=0.22, signed-rank S=34 ). However, we found ease of use score was significantly associated with years of experience working in EMS. All (100%) of students with zero years of experience rated the i-gel® easiest while only 14% of students with 3+ years of experience rated it easiest. Conversely, 100% of students with 3+ years of experience rated the (air-Q®) as easiest as compared to 40% of students with zero years of experience. As noted above, the majority (83%) of supraglottic experience in the cohort was with a laryngeal mask airway.

Table 6.

Ease of use ratings

Simulation Lab Results* Operating Room Results**
i-gel® AuraGain® ETI i-gel® AirQ®

n=58 n=58 n=58 n=22 n=21
1-easiest 52(90%) 10(17%) 4(7%) 16(73%) 11(52%)
2 5(9%) 36(62%) 12(21%) 5(23%) 9(43%)
3 0 11(19%) 14(24%) 1(5%) 1(5%)
4-hardest 1(2%) 1(2%) 28(48%) 0(0.0%) 0(0%)
*

p<0.01 for pairwise comparisons: i-gel®vs AuraGain® (sign rank S=495), AuraGain® vs ETI (sign rank S=493), and i-gel®vs ETI (sign rank S=735)

**

p=0.22 for i-gel®vs AirQ® comparison

One student in the Operating Room arm did not perform both i-gel® and AirQ®

Discussion

In this study we found that the i-gel® and laryngeal mask airways were able to be placed more rapidly than endotracheal tubes by paramedic students, and that both were effective at oxygenating and ventilating patients in the operating room. The i-gel® had the fastest time to placement in the simulation lab; while in the operating room, time to placement between the laryngeal mask airway and the i-gel® was not significantly different. Importantly, students were able to translate the simulation experience to patients and were successful with supraglottic device placements in the operating room. Our results suggest that supraglottic devices, and in particular the i-gel, may be a pediatric airway solution that EMS agencies can deploy with modest training resources among providers with limited pediatric airway experience.

There are several potential reasons for the differences observed in placement times of the two devices between the simulation and operating room. First, the simulation scenario more closely mimicked an EMS patient encounter. Paramedic students had to remove the equipment from pockets of an equipment bag and insert the airway device into the mannequin while CPR was being performed. In contrast, in the operating room the equipment was all prepared prior to the procedure and chest compressions were not being performed during the airway procedure. In the simulation scenarios, participants had to locate a 10 mL syringe to inflate the laryngeal mask cuff in an airway kit, which was kept separate from where the supraglottic devices were kept. We used a commercially available equipment bag packaged according to the standards of the largest EMS agency in our area. Other equipment kits may result in different placement times. Finally, nearly all students tested the cuff of the laryngeal mask in the simulation scenarios, but in the operating room this was typically not done. Our findings suggest that the i-gel® and laryngeal mask airways are both able to be placed quickly once the equipment has been prepared, though cuff inflation may result in modest delays in laryngeal mask airway placement. We believe the actual times observed in the study in controlled environments are not likely what would be seen in the field, and that relative differences between devices are likely amplified in a “real world” environment where stress levels are higher and the environment uncontrolled. Future research should report on supraglottic devices being used in the field, and ideally a prospective randomized trial would be conducted to compare supraglottic devices to ETI and/or bag-valve-mask ventilation.

Overall, the students rated the the i-gel® as easier to use, though these differences were only significant in the simulation lab portion of the study. We found that students with less supraglottic device experience rated the i-gel® as significantly easier to use than the laryngeal mask airway. The supraglottic device experience in our group was highly weighted towards laryngeal mask placements with an average of five previous laryngeal mask placements compared to one i-gel®. Of note, in the simulation lab, the devices were packaged in a standard EMS kit while in the operating room airway devices were prepared and ready before the case began. This likely had a significant effect on ease of use rating differences between the groups since participants in simulation had to locate an inflation syringe and usually tested the inflatable cuff on the Ambu® laryngeal mask for leaks.

There are relatively few studies of supraglottic devices being placed by paramedics in pediatric scenarios. Previous studies have evaluated supraglottic devices when used by paramedics in adults. After brief training, i-gel® airway devices were more successful and rapid to place in adult mannequins compared to laryngeal mask airways or endotracheal tubes among experienced paramedics.23 Another simulation study similarly found that novice paramedics had greater success and better skill retention with supraglottic devices compared to ETI after brief training.24 One randomized trial found that adults with out-of-hospital cardiac arrest had improved survival when a laryngeal tube was used as the initial airway.7 The relative benefits of supraglottic devices may be accentuated in children compared to adults since the even the most extensive training programs and well-designed EMS systems have limited exposure to pediatric airway procedures.22,25 The resources required for EMS agencies to maintain high levels of competency with supraglottic devices is likely significantly less than ETI.

This study took place in controlled environments and may not reflect field performance. This also does not address managing an airway with a supraglottic device in the presence of significant secretions. The paramedic students in the study did not have prior field experience with these devices. However, they did have recent lab training, primarily with the laryngeal mask, which could affect the results. We did not include any laryngeal tube devices in the study since they were not available in comprehensive pediatric sizes at the time the study was developed. Finally, we used different brand laryngeal mask airways between the two portions of the study which could also affect results.

Conclusions

We found that paramedic students were able to place supraglottic devices rapidly with high success rates in simulation lab and operating room environments. Supraglottic devices, particularly the i-gel, were rated as easy to use. The i-gel may be easiest to use since it lacks an inflable cuff and requires fewer steps to place.

What is already known on this subject:

Supraglottic devices such as the laryngeal mask airway and the i-gel® have an established history of successful use by anesthesiologists in the operating room. However, it is unknown how these devices perform, and how easy they are to use, after brief training among paramedic students.

What this study adds:

In this two-phase randomized trial, we found that paramedic students were able to place supraglottic devices, including the laryngeal mask airway and i-gel®, with high success rates in simulation lab and operating room environments. Paramedic students placed both supraglottic devices more rapidly than an endotracheal tube. The i-gel® was the fastest device to place in simulated infant cardiac arrest, and was easier to use by paramedic students with less experience.

Funding Statement

This study was supported by the National Heart Lung and Blood Institute grant # K23 HL131440. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung and Blood Institute or the National Institutes of Health. In addition, Intersurgical, (Workingham, Berkshire, UK) provided i-gel® devices and Ambu, Columbia,MD provided AuraGain™ laryngeal mask devices for the study.

Footnotes

Ethics Approval Statement

This study was approved by the Oregon Health & Science University IRB

Clinical Trial Registration

Not applicable

Competing Interest

None declared.

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