LifeVac Survey Study

• Conditions: Airway Obstruction; Choking

• Registration Number: NCT06659796
• Lead Sponsor: LifeVac, LLC

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.

Study Timeline

• Study Start: 2024-06-24
• Status Verified: 2024-10
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	Up to 1 week	Occurrence of any serious adverse events (SAE) associated with the use of the LifeVac device.
Primary Effectiveness Endpoint	Up to 1 week	Confirm success or partial success in relieving airway obstruction in at least 80% of uses of the device.

Secondary Outcome Measures

Name	Time	Method
Secondary Safety Endpoint	Up to 1 week	Occurrence of any adverse events (AE) associated with the use of the LifeVac device.
Secondary Effectiveness Endpoint	Up to 1 week	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.

Trial Locations

Locations (1)

Boston MedTech Advisors; 🇺🇸 Dedham, Massachusetts, United States