A protocol for the multi-method evaluation of novel externally applied suction-based airway clearance devices in the treatment of foreign body airway obstructions

Abstract Background Foreign body airway obstructions (FBAO, choking) are a significant cause of preventable mortality. Abdominal thrusts, back blows, and chest compressions are traditional interventions; however, suction-based airway clearance devices (anti-choking devices, ACDs) have recently been marketed as an alternative. Of note, there is limited published evidence regarding their efficacy and safety. Our research has two aims: 1) To investigate what situational and patient factors are frequently identified, and which are associated with relief of the FBAO, and survival, in individuals with a FBAO treated with an ACD; and 2) To describe the experience of individuals who have used ACDs in response to a FBAO and identify facilitators and barriers to the use of ACDs compared to traditional interventions. Methods and analysis All ACD case reports collected a priori by manufacturers will be analyzed up to July 1st, 2021. Following, a prospective database will be developed using an online reporting system to capture future ACD use from July 1st, 2021 to Dec 31st, 2023. Descriptive statistics will be used to summarize cases, 58 outcomes, and adverse events. Where possible, bivariable and multivariable analysis will be employed to assess for predictors of outcomes (relief of FBAO, survival, and survival with good neurological function). Semi-structured interviews will be conducted with a subset of ACD users to describe in detail their experience using the device. Themes from these interviews will be assessed using the Theoretical Domains Framework. Ethics and dissemination This study has ethics approval from the University of New South Wales Human Research Ethics Committee (HC210242). Findings from this multi-year, multi-method study will be published in peer reviewed literature, presented at conferences and contribute to informing future resuscitation guidelines. Data on ACDs are urgently needed as these devices are already being used by parents, caregivers, lay rescuers, and healthcare professionals to respond to choking emergencies. Strengths and limitations of the study ∘ Foreign body airway obstruction (FBAO) intervention is an area with limited data, largely based on retrospective case series for traditional techniques (e.g., abdominal thrusts, back blows and chest thrusts) ∘ A multi-phase, multi-year study will be conducted to evaluate a novel intervention (suction-based airway clearance devices, ACDs) that have the potential to improve pre-hospital response to foreign body airway obstructions and survival ∘ Utilization of retrospective and prospective data, as well as evaluation of the users’ experience, will help determine the role for airway clearance devices in resuscitation algorithms and future guidelines ∘ Data will be reliant on self-reporting from users due to the infrequent occurrence of FBAO and few ACDs available to general public ∘ Previous studies have relied on data collected by manufacturers, which will be improved here by providing users with an independent reporting method

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