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OpenTrials
Enrolling by Invitation

NCT Number: NCT06805838

Prolonged Manual Ventilation Simulation

A pilot study on simulated lung scenarios using the standard manual resuscitator bag, flow limiting resuscitator bag, and an FDA approved flow rate limiting device paired with a standard manual resuscitator.

Enrolling by Invitation

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Key information

Conditions

Manual Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown Physicians, Inc

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old or older
  • Have a current basic life support (BLS) certification
  • Be available for the entire 10 hours to complete the protocol

Exclusion criteria

  • Any training in medical school or respiratory therapy school
  • Not being available for the full 10 hours to complete the protocol

Treatment and study plan

Sotair

Device

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."

Primary outcomes

  1. Minute ventilation while manually ventilating the simulated lung

    Time frame: 10 hours of manual ventilation

    The primary Ventilation endpoint is minute ventilation while manually ventilating the simulated lung over the course of 10 hours.

  2. Minute ventilation while manually ventilating the simulated lung

    Time frame: 10 hours of manual ventilation

    The major endpoints of the subjects response to performing the manual ventilation will be: Respiratory rate and heart rate; Samn-Perelli 7-point fatigue scale reported hourly; Modified Borg Rating of Perceived Exertion 10-point scale reported hourly.

Secondary outcomes

  1. Secondary Outcome Measure

    Time frame: 10 hours of manual ventilation

    Secondary endpoints include: tidal volume, peak inspiratory pressure, respiratory rate, and estimated alveolar ventilation while ventilating the simulated lung.

Sponsors and collaborators

Lead sponsor

SafeBVM

Industry

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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