ABSTRACT
Introduction: The LuboTM collar is a cervical motion restriction device featuring a unique external jaw-thrust mechanism designed to provide non-invasive airway patency. In addition, tracheal intubation is facilitated by releasing an anterior chin strap; this allows better mouth opening than the previous generation of semi-rigid cervical collars. This study aimed to compare tracheal intubation using the LuboTM collar combined with manual in-line stabilization (MILS) to intubation with MILS alone. The primary outcome was the time to successful intubation. Secondary outcomes compared intubation success rate, Cormack-Lehane grade, ease of intubation and dental trauma. Methods: A randomized, cross-over, equivalence study was performed. Eighty full-time physician anaesthesia providers were recruited. Participants performed tracheal intubation using direct laryngoscopy on a manikin under two different scenarios: with the LuboTM collar and MILS applied, and with MILS and no cervical collar. The time to successful intubation was measured and compared using two-one-sided and paired t-tests. Results: Intubation times fell well within the a priori equivalence limits of 10 seconds, with a mean difference (95% CI) of 0.52 seconds (-1.30 to 2.56). There was no significant difference in intubation time with the LuboTM collar (mean [SD] 19.2 [4.5] seconds) compared to the MILS alone group (19.7 [5.2] seconds). The overall success rate was 98.7% in the Lubo group and 100% in the MILS group. Adequate laryngoscopy views (Cormack-Lehane grades I to IIb) were equivalent between groups (Lubo 92.5% versus MILS alone 93.7%). Conclusion: In this manikin-based study, the time to intubation with the LuboTM collar and MILS applied was equivalent to time to intubation with MILS alone, with similar intubating conditions. Thus, the LuboTM collar and MILS may simplify airway management by reducing the number of steps required to perform intubation in patients requiring cervical motion restriction.
ABSTRACT
INTRODUCTION: Intended for use by prehospital first responders, the Lubo TM cervical collar is an adjustable, radiolucent, single-use device that incorporates a mechanical jaw thrust mechanism. The combination enables non-invasive airway management in cases of trauma where cervical motion restriction is necessary. The potential benefits include use as an airway adjuvant maintaining upper airway patency, reducing provider task loading. The limited research on the device efficacy and safety requires further investigation. METHODS: A randomized, crossover, interventional study was performed to compare mean differences in airway patency at the level of the uvula, epiglottis, tongue and soft palate with and without the Lubo collar in awake volunteers using magnetic resonance imaging (MRI). Fourteen participants each underwent two MRI scans of the upper airway: A control scan with no Lubo collar, and an intervention scan with the Lubo collar applied and jaw thrust mechanism activated. Two independent radiologists measured anterior-posterior diameter of the airway at four anatomical levels on the resulting MRI images. RESULTS: There was no significant difference in mean airway diameter between the control and intervention measurements at any level. Mean (SD; 95% CI: p-value) differences were 0.9 mm (-2.38; 2.3 to 0.5; p=0.17) at the epiglottis, 0.5 mm (1.6; -0.5 to 1.4; p=0.29) at the soft palate, 0.2 mm (2.86; -1.4 to 1.9; p = 0.78) at the tongue, 0.4 mm (4.04; -1.9 to 2.7; p = 0.72) at the uvula. CONCLUSION: The Lubo TM airway collar did not show a significant change in upper airway patency at four anatomical levels measured in awake adult participants. Further research is required to investigate its clinical use in patients that are unable to maintain upper airway tone. Groups of interest would include trauma, obstructive sleep apnoea, obesity and patients under general anaesthesia.
