Clinical trial NCT06659796: LifeVac Survey Study
Official title: LifeVac Survey Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Airway Obstruction
Choking
Keywords: Airway obstruction
Choking
Lead sponsor: LifeVac, LLC
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 52
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: • Purchasers of the LifeVac device in the USA from 2015 to April 2024

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Purchases of the LifeVac device Original database: all purchasers of the LifeVac device from the LifeVac website starting in 2015 until April 2024, a timeframe that yields a database of above 450,000 individuals with no email duplications and third party suppliers.

Survey batches: randomly selected sample of 50,000 purchasers (10% of the database).

Number of batches required will be based on response rate.

* English speaking
* Ability to understand and accept the consent form

Exclusion Criteria:

* Did not purchase a LifeVac device
* Third party suppliers
* Non-English speakers (as LifeVac labeling and survey materials are only available in English)
* Unwilling or unable to accept the consent form

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: Up to 1 week
measure: Primary Effectiveness Endpoint
timeFrame: Up to 1 week
Secondary outcomes:
measure: Secondary Safety Endpoint
timeFrame: Up to 1 week
measure: Secondary Effectiveness Endpoint
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Dedham
country: United States
facility: Boston MedTech Advisors
state: Massachusetts
Study officials:
affiliation: Boston MedTech Advisors
name: Andrea Nadai
role: PRINCIPAL_INVESTIGATOR
References: