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Prolonged Manual Ventilation Simulation

NCT06805838 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Manual Ventilation

Interventions

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."

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • SafeBVM

    lead INDUSTRY

Principal Investigators

  • Mark Brady, MD · Brown Physicians, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-25
Primary Completion
2026-01-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06805838 on ClinicalTrials.gov