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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Manual Ventilation
• Intervention / Treatment: Device: Sotair

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Brown Physicians, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Ambu + Normal lung compliance; Manual ventilation with Ambu bag and normal lung compliance.
No Intervention: Ambu + Low lung compliance; Manual ventilation with Ambu bag and low lung compliance.
No Intervention: Smart bag + Normal lung compliance; Manual ventilation with smart bag and normal lung compliance.
No Intervention: Smart bag + Low lung compliance; Manual ventilation with smart bag and low lung compliance.
Active Comparator: Ambu + Sotair + Normal lung compliance; Manual ventilation with Ambu bag and Sotair device with normal lung compliance.	Device: 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."
Active Comparator: Ambu + Sotair + Low compliance; Manual ventilation with Ambu bag and Sotair device with low lung compliance.	Device: 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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minute ventilation while manually ventilating the simulated lung	The primary Ventilation endpoint is minute ventilation while manually ventilating the simulated lung over the course of 10 hours.	10 hours of manual ventilation
Minute ventilation while manually ventilating the simulated lung	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.	10 hours of manual ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome Measure	Secondary endpoints include: tidal volume, peak inspiratory pressure, respiratory rate, and estimated alveolar ventilation while ventilating the simulated lung.	10 hours of manual ventilation

Collaborators and Investigators

• Sponsor: SafeBVM
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Mark Brady, MD, Brown Physicians, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: tidal volume; Prolonged manual ventilation simulation; BVM; Sotair; BLS certification; peak inspiratory pressure
• Other Study ID Numbers: DoD Ventilation Study; HT94252310316 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Decision has not been determined.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No