Article

High-speed handling of a haemorrhage control system by first-responders and physicians

838 Correspondence / American Journal of Emergency Medicine 38 (2020) 827848

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    High-speed handling of a haemorrhage control system by first-responders and physicians

    Rapid haemorrhage control is critical to trauma patient outcome [1, 2]. Even when blood loss is not life threatening, a patient’s clinical con- dition may worsen in the absence of Bleeding control [2]. An effective, fast, and easy-to-use tool to stop bleeding is much needed in emergency medicine [3].

    A clamp that approximates the edges of a wound and stops bleeding would be a convenient tool for use in emergency medicine, especially in the pre-hospital setting. The ideal tool would be easy to use, similarly to the tourniquet and haemostatic agents by militaries in field care [3].A new device, the iTClamp(TM) might meet the required specifications. The iTClamp(TM) is a simple physical tissue compression device that has dem- onstrated efficacy when used by physicians in exsanguinating haemor- rhage (Fig. 1) [4-8]. However the greatest impact of such a device would be expected from its use by the first on scene, i.e. First responders. The aim of this study was to assess the feasibility of the application of a haemostatic clamp by first responders and physicians. A model-bleed- ing limb was used, following the showing of a very short instruction video. This was a simulation study, approved by the local ethics commit- tee (Comite de protection des personnes, Aulnay sous bois CPP X). Par- ticipants were emergency physicians with experience in trauma in the pre-hospital setting and first responders from the French Red Cross. No participant had ever seen an iTClamp(TM). The Experimental model was a manufactured silicon-coated polymer arm equipped with a pump that simulated bleeding from a pulsatile, arterial wound but with no control of flow rate. The exsanguinated simulated blood

    (water with red food dye) was collected from the arm in a container.

    Participants were shown a 47-s video explaining clamp application and given the opportunity to ask questions [9]. The investigator then started up the pump model to simulate bleeding and, after 30 s, gave the signal for clamp application. Participants took the clamp out of the nearby box and applied it to the limb. Each procedure was recorded on video. Investigators recorded time to apply the device and volume of simulated blood loss at 15-s intervals, measured with a scale, by watching the recordings.

    We hypothesised that first responders’ performance were non-infe- rior to emergency physicians’. In a pilot and unpublished study, physi- cians took 14 s to apply the clamp. Participant numbers were estimated on the basis of a time difference no greater than 25% (3.5 s), a 5% alpha risk and 80% power, plus an additional 10%, i.e. 30 partici- pants per group. Non-inferiority was tested using the confidence inter- vals method [10]. Our interval was ]-3.5 – +?[. Other comparisons were performed using the chi-squared test or the Mann-Whitney test. We used R software (V3.1.0).

    A total of 33 emergency physicians and 35 first responders com- pleted the procedure. Unexpected premature clamp closure occurred during procedures carried out by 40% of participants (12 physicians and 15 first responders, p = 0.6). One clamp was considered to be inap- propriately applied (by a physician) as blood flow was not adequately controlled.

    Median time to arrest blood flow through clamping was 14 [11-18] seconds for physicians and 15 [12-18] seconds for first responders (Fig. 2). The mean difference between the two groups was -0.34 +- 1.77 s. Non-inferiority was statistically confirmed as the calculated interval of [-2.11-1.43] seconds was within our hypothesis interval.

    First responders applied the clamp to our model of bleeding as quickly as the emergency physicians. This is not the first time that first responders have performed as well as doctors. Indeed, we have previ- ously reported faster reactions of first responders in the use of an auto- mated device for external chest compressions [11]. Physicians placed the automated device faster but took more time to start it up, potentially because their medical training leads them to question device suitability before use.

    There were several limitations in this study. Firstly, the training video did not deal with unexpected premature closure of the iTClamp(TM), which participants were therefore ill equipped to manage. The iTClamp(TM) is a single use device, with a safety seal on it that breaks on the first application making unexpected closure more likely on future applications. This was problematic for this study because a new iTClamp(TM) was not used for each new application. Secondly, a significant limitation of this study was the use of an experimental model. This does not, however, impact on the conclusion that clamp use by first re- sponders is feasible and that a very short training video is effective.

    Rapid control of bleeding is critical in many trauma cases [12]. First responders, already present or first at the scene, should be equipped with rapid haemorrhage control device. Our results suggest that the iTClamp(TM) meets the required specifications for rapid haemorrhage control and could be entrusted to non-physicians to control bleeding from limb or scalp wounds.

    Fig. 1. iTClamp(R).

    Correspondence / American Journal of Emergency Medicine 38 (2020) 827848 839

    Fig. 2. Weight of collected blood simulant every 15 s over a period of 2 min in the model of bleeding from a limb wound (black line) and after the use of iTClamp by physicians (red line) or first-aid workers (green line) (median – 25-75 percentiles).

    Funding

    Teleflex Medical Europe kindly provided all training materials (poly- mer limb, clamp) and paid for manuscript translation costs.

    Author contributions

    Frederic Lapostolle: study design, data analysis, Data interpretation and preparation of the manuscript.

    Paul-Georges Reuter: data analysis, data interpretation and prepara- tion of the manuscript.

    Sarah Tepper: data acquisition, data interpretation.

    Antoine Lesecq, Camille Freedman, Jean-Marc Agostinucci, Hayatte Akodad: data acquisition.

    Frederic Adnet: critical revision.

    Tomislav Petrovic: data interpretation and critical revision.

    Financial support

    Teleflex Medical Europe kindly provided all training materials (poly- mer limb, clamp) and paid for manuscript translation costs.

    Declaration of Competing Interest

    Frederic Lapostolle has received honoraria as conference speaker from Teleflex Medical Europe. Remaining authors have no conflicts of interest to declare in relation to Teleflex Medical.

    Paul-Georges Reuter*

    Sarah Tepper Hayatte Akodad Antoine Lesecq a Tomislav Petrovic Frederic Adnet Frederic Lapostolle

    SAMU93 – UF Recherche-Enseignement-Qualite, Universite Paris 13 Sorbonne Paris Cite, Inserm U942, Hopital Avicenne, 125, rue de

    Stalingrad, 93009 Bobigny, France

    Camille Freedman Jean-Marc Agostinucci

    bcroix rouge francaise, PST93, Sevran, France

    *Corresponding author.

    E-mail address:[email protected] (P.-G. Reuter)

    Received 7 May 2019

    Received in revised form 25 September 2019

    Accepted 1 October 2019

    https://doi.org/10.1016/j.ajem.2019.158498

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