Prolonged Manual Ventilation Simulation

Conditions

• Manual Ventilation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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."

Study Details

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.

Key Dates

Start date

Jan 25, 2025

Status verified

Feb 2025

Primary completion

Jan 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

102 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• 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.
• Active Comparator: Ambu + Sotair + Low compliance
  Manual ventilation with Ambu bag and Sotair device with low lung compliance.

Primary Outcome Measure

Minute ventilation while manually ventilating the simulated lung [ Time Frame: 10 hours of manual ventilation ]

Locations (1)

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