Trial reportScandinavian journal of trauma, resuscitation and emergency medicine2018
Comparison of a novel, endoscopic chest tube insertion technique versus the standard, open technique performed by novice users in a human cadaver model: a randomized, crossover, assessor-blinded study.
Trial report in Scandinavian journal of trauma, resuscitation and emergency medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors at 1 institution in 1 country.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundThe technique of tube thoracostomy has been standardized for years without significant updates. Alternative procedural methods may be beneficial in certain prehospital and inpatient environments with limited resources. We sought to compare the efficacy of chest tube insertion using a novel, endoscopic device (The Reactor™) to standard, open tube thoracostomy.
methodsNovice users were randomly assigned to pre-specified sequences of six chest tube insertions performed on a human cadaver model in a crossover design, alternating between the Reactor™ and standard technique. All subjects received standardized training in both procedures prior to randomization. Insertion site, which was randomly assigned within each cadaver's hemithorax, was marked by the investigators; study techniques began with skin incision and ended with tube insertion. Adequacy of tube placement (intrapleural, unkinked, not in fissure) and incision length were recorded by investigators blinded to procedural technique. Insertion time and user-rated difficulty were documented in an unblinded fashion. After completing the study, participants rated various aspects of use of the Reactor™ compared to the standard technique in a survey evaluation.
resultsSixteen subjects were enrolled (7 medical students, 9 paramedics) and performed 92 chest tube insertions (n = 46 Reactor™, n = 46 standard). The Reactor™ was associated with less frequent appropriate tube positioning (41.3% vs. 73.9%, P = 0.0029), a faster median insertion time (47.3 s, interquartile range 38-63.1 vs. 76.9 s, interquartile range 55.3-106.9, P < 0.0001) and shorter median incision length (28 mm, interquartile range 23-30 vs. 32 mm, interquartile range 26-40, P = 0.0034) compared to the standard technique. Using a 10-point Likert scale (1-easiest, 10-hardest) participants rated the ease of use of the Reactor™ no different from the standard method (3.8 ± 1.9 vs. 4.7 ± 1.9, P = 0.024). The Reactor™ received generally favorable scores for all parameters on the post-participation survey.
conclusionsIn this randomized, assessor-blinded, crossover human cadaver study, chest tube insertion using the Reactor™ device resulted in faster insertion time and shorter incision length, but less frequent appropriate tube placement compared with the standard technique. Additional studies are needed to evaluate the efficacy, safety and potential advantages of this novel device.
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