Airway ObstructionNCT06659796
LifeVac Survey Study
An observational study of Airway Obstruction and Choking, run by LifeVac, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Airway Obstruction, Choking
- What is being tested?
- LifeVac
- Type of treatment
- Medical device
- How many people
- 2,930 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: • Purchasers of the LifeVac device in the USA from 2015 to April 2024
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston MedTech Advisors
Dedham, Massachusetts, 02026
About this study
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:
- Is the LifeVac device safe for individuals experiencing a choking emergency?
- Is the LifeVac device successful in removing an obstruction during a choking incident?
Participants: Purchasers of the LifeVac device.
Read the 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:
- Gather information on device usage patterns and user experiences with the LifeVac airway clearance device.
- 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:
- Purchasers will be invited to participate via a standardized email with a link to an online platform (IntelliSurvey, Inc.) independent of the device manufacturer.
- Participation will require electronic consent before accessing the survey.
- The survey is accessible through a web browser and can be completed on a desktop computer or mobile device.
- Conditions
- Airway Obstruction, Choking
- Being tested
- LifeVac
- Keywords
- Airway obstruction, Choking
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeVacDevice
Removal of airway obstruction during choking emergency
| Study group | Role | What they receive |
|---|---|---|
| Users of LifeVac device | Individuals who have used the LifeVac device during a choking emergency Receives: Device: LifeVac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Occurrence of any serious adverse events (SAE) associated with the use of the LifeVac device.
Measured: 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.
Measured: Up to 1 week
Secondary outcomes (2)
Secondary Safety Endpoint
Occurrence of any adverse events (AE) associated with the use of the LifeVac device.
Measured: 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.
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start24 Jun 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,930 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeVac, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Nadai, Principal investigator, Boston MedTech Advisors
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659796
- Sponsor's protocol ID
- 2024-001
- Status last verified
- Jul 2025
- First submitted
- 21 Oct 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LifeVac Survey Study
- ClinicalTrials.gov ID
- NCT06659796
- Acronym / sponsor ID
- 2024-001
- Conditions
- Airway Obstruction, Choking
- Keywords
- Airway obstruction, Choking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,930 participants (actual)
- Lead sponsor
- LifeVac, LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the LifeVac device safe for individuals experiencing a choking emergency?
- 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:
- Gather information on device usage patterns and user experiences with the LifeVac airway clearance device.
- 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:
- Purchasers will be invited to participate via a standardized email with a link to an online platform (IntelliSurvey, Inc.) independent of the device manufacturer.
- Participation will require electronic consent before accessing the survey.
- The survey is accessible through a web browser and can be completed on a desktop computer or mobile device.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Users of LifeVac device | – | Device: LifeVacIndividuals who have used the LifeVac device during a choking emergency |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- • Purchasers of the LifeVac device in the USA from 2015 to April 2024
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifeVacRemoval of airway obstruction during choking emergency | Device | Users of LifeVac device |
Primary outcome
Primary Safety Endpoint
Time frame: Up to 1 week
Occurrence of any serious adverse events (SAE) associated with the use of the LifeVac device.
Primary Effectiveness Endpoint
Time frame: Up to 1 week
Confirm success or partial success in relieving airway obstruction in at least 80% of uses of the device.
2 secondary outcomes
Secondary Safety Endpoint
Time frame: Up to 1 week
Secondary Effectiveness Endpoint
Time frame: Up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Nadai principal investigator
Boston MedTech Advisors
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Obstruction and Choking, run by LifeVac, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: Up to 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.