Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
102 participants
INTERVENTIONAL
2025-01-25
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Ambu + Normal lung compliance
Manual ventilation with Ambu bag and normal lung compliance.
No interventions assigned to this group
Ambu + Low lung compliance
Manual ventilation with Ambu bag and low lung compliance.
No interventions assigned to this group
Smart bag + Normal lung compliance
Manual ventilation with smart bag and normal lung compliance.
No interventions assigned to this group
Smart bag + Low lung compliance
Manual ventilation with smart bag and low lung compliance.
No interventions assigned to this group
Ambu + Sotair + Normal lung compliance
Manual ventilation with Ambu bag and Sotair device with normal lung compliance.
Sotair
The device is a durable plastic connector with a silicone flap inside it requiring no special handling. There are no patients involved, only a simulated lung that also requires no special handling. Adult Sotair® device has FDA clearance as a Class II device through the 510(k) pathway (K212905) for the intended use of "Flow-limiting, safe, and optimal manual ventilation to minimize gastric insufflation."
Ambu + Sotair + Low compliance
Manual ventilation with Ambu bag and Sotair device with low lung compliance.
Sotair
The device is a durable plastic connector with a silicone flap inside it requiring no special handling. There are no patients involved, only a simulated lung that also requires no special handling. Adult Sotair® device has FDA clearance as a Class II device through the 510(k) pathway (K212905) for the intended use of "Flow-limiting, safe, and optimal manual ventilation to minimize gastric insufflation."
Interventions
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Sotair
The device is a durable plastic connector with a silicone flap inside it requiring no special handling. There are no patients involved, only a simulated lung that also requires no special handling. Adult Sotair® device has FDA clearance as a Class II device through the 510(k) pathway (K212905) for the intended use of "Flow-limiting, safe, and optimal manual ventilation to minimize gastric insufflation."
Eligibility Criteria
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Inclusion Criteria
* Have a current basic life support (BLS) certification
* Be available for the entire 10 hours to complete the protocol
Exclusion Criteria
* Not being available for the full 10 hours to complete the protocol
18 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
SafeBVM
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Brady, MD
Role: PRINCIPAL_INVESTIGATOR
Brown Physicians, Inc.
Locations
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Brown Physicians, Inc
Providence, Rhode Island, United States
Countries
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Other Identifiers
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HT94252310316
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DoD Ventilation Study
Identifier Type: -
Identifier Source: org_study_id
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