Our study is the first that aimed to assess, in a simulated scenario, the handling of new anti-choking devices (LifeVac® and DeCHOKER®) and to compare them with the recommended choking protocol by laypeople at risk of witnessing an FBAO: parents and kindergarten teachers. We observed that most participants achieved a higher success rate in managing FBAO using both anti-choking devices than with the currently recommended protocol. However, they often failed fitting and keeping the mask to the victim's airway. When devices were compared with each other, participants needed less time when using the LifeVac®, although in both cases, the mean total time was slightly shorter than one minute.
The main goal of the FBAO treatment is the removal of the obstruction as early as possible without injury to the victim, which means that bystanders are the target population to solve it [19,20]. Controversy about FBAO management is rooted on the limited evidence supporting these interventions, which are mainly based on case series and experts' opinion, and on the potential harms associated with these techniques [13]. This leads to a continuous search for a safe and effective alternative.
Previously published information and evidence on the new anti-choking devices are extremely limited and unconclusive. The recent systematic review by Dunne et al. [17] includes only five studies about the LifeVac® device, two of them on manikins [21, 22], one on a cadaver [23] and the others were case series [24,25] which report a high success rate for FBAO removal, in most cases in the first few attempts. However, these references are seriously biased (industrial involvement, measurement of outcomes, selection, and information bias, with hardly any information on the methodology used, imprecise results...) [17].
Up to now, only two new articles have been published since the above-mentioned review. In one study, the DeCHOKER® device was evaluated in 27 real choking victims, 26 of whom were successfully removed the obstruction with the device [26]. The other study, a manikin randomized crossover trial conducted with medical students, compared abdominal thrust, LifeVac®, and DeCHOKER® device and found a higher estimated success rate for FBAO removal with the LifeVac® device [19]. For these reasons, the need for further studies on this issue has been suggested [16,17].
The estimated success rate, calculated by taking into account the correct performance of all steps in each sequence, showed significantly better results for the anti-choking devices (without significant differences between them). In other words, participants found it easier to use the brand-new LifeVac® and DeCHOKER® devices as they did so with fewer errors than following the recommended protocol.
However, it has to be noted that, although instructions were provided for all three situations, we observed that participants followed the instructions more carefully in the case of the anti-choking devices perhaps because they were completely new tools to them. On the other hand, in the case of the recommended standard protocol, they often acted instinctively or according to their prior knowledge without strictly paying attention and following the displayed instructions. This may explain why there were more errors while performing the recommended protocol sequence. In fact, only 5.9% of the participants performed all steps correctly compared to 51% with LifeVac® and 56.9% with DeCHOKER® devices.
One of the main problems blamed on these devices is that they can distract rescuers and cause a delay in the recommended techniques (such as back blows and abdominal thrust) [8,16,17,19]. However, in our study, participants spent less than one minute to apply the LifeVac® and DeCHOKER® devices to solve the FBAO simulation. Although our study did not assess the effective FBAO successful removal, the results agree with those of the study by Patterson et al. [19] who showed a higher number of successful FBAO removal in a shorter time with the LifeVac® device (82% in the first minute compared to 44% cases using DeCHOKER® and 67% using abdominal thrusts). Nevertheless, the three situations are not entirely comparable as the devices are theoretically recommended when the choking protocol fails [14,15].
When devices were compared with each other, both had similar success rates. Of the entire procedure, the most difficult step for the participants was the one related to fitting and keeping the mask to the victim's airway. This is a remarkable fact because although participants spent less time in the process with the LifeVac® device, they had more difficulties with the mask seal. In this line, the successful removal of a FBAO using devices depends on the generation of a strong negative pressure associated with an effective mask seal [19]. Previous studies using facemask also reported difficulty of use, especially for novices and above all with one-hand technique [27,28]. In this sense, further studies are needed to corroborate our preliminary results.
Regarding the management of a FBAO simulation acting according to recommended protocol, we have found that most participants (94.1%) gave abdominal thrusts and many also gave the back blows (76.5%). However, when it came to performing these steps correctly, we found that more participants who had received prior training did significantly better. As mentioned, the estimated success rate of executing the steps was lower than with the anti-choking devices. And, in turn, participants with prior training achieved a significantly higher rate. Although no previous studies on evaluating the effect of training on the choking recommended protocol have been found, our results might be related to other studies where different methods of training in BLS content, such as AED [29], and adult [30,31] and pediatric [32] CPR, improved performance outcomes.
Based on our results, we consider that the anti-choking devices are easy to use but a short training would be needed to reduce errors and take advantage of the devices' function. Further evidence on the efficacy of these devices is needed in order to be able to recommend their use as previously reported [17,18]. In agreement, the 2021 European Resuscitation Council Guidelines of Basic Life Support [33] maintain the prior recommendations for the management of a FBAO and insist that alternative techniques lack sufficient evidence for their introduction into the guidelines at this moment.
Limitations
Our study is not free of limitations. First, we conducted a simulation manikin study that involves two weaknesses: the manikin doesn't exactly reflect the characteristics of a real victim and participants might have different attitudes compared to a real FBAO scenario. Moreover, the manikin was a standard CPR model, not a specific one for FBAO. Although there are manikins for FBAO situations, they were not created for the evaluation of anti-choking devices effectiveness. Thus, no manikins exist that would allow reliable evaluation of the effectiveness of these devices. On the other hand, for the recommended protocol test we used a real person to simulate the FBAO instead of a manikin due to the particular characteristics of the manikin did not allow the technique to be executed correctly. Our sample was small and specific: parents and teachers in a kindergarten, which makes it necessary to interpret the results with caution and not to extrapolate them to the general population.
In addition, the success rate variable, calculated to compare quantitatively the three situations, has the limitation that in each test was calculated based on a different number of items (recommended protocol 8 items, LifeVac® 6 items, and DeCHOKER® 4 items).