A Protocol for the Prospective Evaluation of Novel Suction-Based Airway Clearance Devices in the Treatment of Foreign Body Airway Obstructions

Abstract

BackgroundForeign body airway obstructions (FBAOs, choking) are a significant cause of preventable mortality. Abdominal thrusts, back blows, and chest compressions are traditional interventions. However, suctionbased airway clearance 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 FBAOs 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 analysisA prospective database will be developed using an online reporting system to capture ACD uses, independent of manufacturers, from July 1st, 2021 to December 31st, 2023. Descriptive statistics will be used to summarize cases, outcomes, and adverse events. Clinically important subgroups will be stratified for analysis, including the severity of obstruction, patient demographics, and training of ACD users. Semistructured interviews will also 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. DiscussionThis study will improve the evidence surrounding ACDs and compare it to current data for traditional techniques, with the aim of optimizing FBAO treatment. 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. This evaluation will provide important information about their effectiveness and any safety concerns which can inform the public, resuscitation guidelines, and future research studies.

Phase One of a Global Evaluation of Suction-Based Airway Clearance Devices in Foreign Body Airway Obstructions: A Retrospective Descriptive Analysis

“…Airway clearance devices appear to have the potential to help save lives. This study is the first of a multi-phase global evaluation of ACDs that aims to determine their effectiveness and clarify their role (if any) in future choking intervention algorithms [ 15 ]. Prior to this study, most published data were limited to mannequin studies, case reports with few entries, or only focused on a subset of the population [ 8 , 9 , 14 , 21 , 22 ].…”

“…While a self-reporting methodology is inevitable presently, data that are prospectively collected, industry-distanced, with medical oversight and follow up, will shed more light on the role ACDs could play in the treatment of choking. One such study is ongoing, though multiple investigations are needed [ 15 ].…”

“…The start date represents the earliest report of an ACD intervention to device manufacturers. A detailed description of the study development and methodology has been published previously [ 15 ]. A brief summary is presented below.…”

“…This retrospective analysis is the first phase in a multi-method global evaluation of ACDs, which aims to fill this knowledge gap [ 15 ]. The objective of this study is to describe what situational and patient factors have been identified in cases where ACDs were used, as well as report on patient outcomes.…”