Prolonged Manual Ventilation Simulation

SafeBVM

Status: Invitation-only

Conditions: Manual Ventilation

Treatments: Device: Sotair

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT06805838

HT94252310316 (Other Grant/Funding Number)

DoD Ventilation Study

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 6 patient groups

Ambu + Normal lung compliance

No Intervention group

Description:

Manual ventilation with Ambu bag and normal lung compliance.

Ambu + Low lung compliance

No Intervention group

Description:

Manual ventilation with Ambu bag and low lung compliance.

Smart bag + Normal lung compliance

No Intervention group

Description:

Manual ventilation with smart bag and normal lung compliance.

Smart bag + Low lung compliance

No Intervention group

Description:

Manual ventilation with smart bag and low lung compliance.

Ambu + Sotair + Normal lung compliance

Active Comparator group

Description:

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

Treatment:

Device: Sotair

Ambu + Sotair + Low compliance

Active Comparator group

Description:

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

Treatment:

Device: Sotair