NCT06805838

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2025Jul 2026

First Submitted

Initial submission to the registry

January 23, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

January 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

August 28, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

January 23, 2025

Last Update Submit

August 27, 2025

Conditions

Manual Ventilation

Keywords

Prolonged manual ventilation simulationBVMSotairBLS certificationtidal volumepeak inspiratory pressure

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Secondary Outcome Measure

    10 hours of manual ventilation

Study Arms (6)

Ambu + Normal lung compliance

NO INTERVENTION

Manual ventilation with Ambu bag and normal lung compliance.

Ambu + Low lung compliance

NO INTERVENTION

Manual ventilation with Ambu bag and low lung compliance.

Smart bag + Normal lung compliance

NO INTERVENTION

Manual ventilation with smart bag and normal lung compliance.

Smart bag + Low lung compliance

NO INTERVENTION

Manual ventilation with smart bag and low lung compliance.

Ambu + Sotair + Normal lung compliance

ACTIVE COMPARATOR

Manual ventilation with Ambu bag and Sotair device with normal lung compliance.

Device: Sotair

Ambu + Sotair + Low compliance

ACTIVE COMPARATOR

Manual ventilation with Ambu bag and Sotair device with low lung compliance.

Device: Sotair

Interventions

SotairDEVICE

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 complianceAmbu + Sotair + Normal lung compliance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown Physicians, Inc

Providence, Rhode Island, 02903, United States

Location

Study Officials

  • Mark Brady, MD

    Brown Physicians, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2025

First Posted

February 3, 2025

Study Start

January 25, 2025

Primary Completion

January 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

August 28, 2025

Record last verified: 2025-02

Locations

US(1)