This observational, non-interventional survey study is intended to explore user experiences with the LifeVac airway clearance device, with a particular emphasis on real-world application in choking emergencies in the USA. This study seeks to gather valuable insights from a representative sample of the LifeVac device purchaser base. The main questions the study aims to answer are: 1. Is the LifeVac device safe for individuals experiencing a choking emergency? 2. Is the LifeVac device successful in removing an obstruction during a choking incident? Participants: Purchasers of the LifeVac device.
Foreign Body Airway Obstruction (FBAO), commonly referred to as choking, occurs when an aspirated solid or semisolid object becomes lodged in a person's larynx or trachea. If the object is large enough it may cause the complete (or near complete) obstruction of the airway. Without oxygen, brain damage can occur in as soon as four minutes following the event. LifeVac is a non-powered, non-invasive, single-use airway clearance device developed for resuscitating a victim with an airway obstruction when current choking protocols (basic life support \[BLS\]) failed to remove the obstruction. The device is intended be used on adults and children, in home and non-home settings, and can be administered by professional/HCP users or laypersons without professional training in a choking emergency. This observational, non-interventional survey study will be conducted on purchasers of the LifeVac device. The study intends to obtain responses from at least 26 users of the device in each of the two age groups of interest, individuals up to 19 years of age (pediatric) and above 20 years of age (adult), and capture unbiased information on the device users' experience, regardless of its outcome. Objectives: 1. Gather information on device usage patterns and user experiences with the LifeVac airway clearance device. 2. Collect data on the safety and effectiveness of the device in real-world choking interventions. Target Population: Purchasers of the LifeVac device in the USA from 2015 to April 2024. Data Collection Procedure: 1. Purchasers will be invited to participate via a standardized email with a link to an online platform (IntelliSurvey, Inc.) independent of the device manufacturer. 2. Participation will require electronic consent before accessing the survey. 3. The survey is accessible through a web browser and can be completed on a desktop computer or mobile device.
Study Type
OBSERVATIONAL
Enrollment
2,930
Removal of airway obstruction during choking emergency
Boston MedTech Advisors
Dedham, Massachusetts, United States
Primary Safety Endpoint
Occurrence of any serious adverse events (SAE) associated with the use of the LifeVac device.
Time frame: Up to 1 week
Primary Effectiveness Endpoint
Confirm success or partial success in relieving airway obstruction in at least 80% of uses of the device.
Time frame: Up to 1 week
Secondary Safety Endpoint
Occurrence of any adverse events (AE) associated with the use of the LifeVac device.
Time frame: Up to 1 week
Secondary Effectiveness Endpoint
Explore potential correlations between the outcome of the device use with age of the choking person, the nature of the obstruction, and the environment where the choking incident transpired.
Time frame: Up to 1 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.