Superiority Trial Between Sotair® Device Attached to Manual Resuscitator

Status Recruiting

Clinical Trial Summary

Effective respiratory ventilation is achieved by moving the right amount of air to and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.

Clinical Trial Description

Poor manual ventilation technique is a well-documented problem which occurs irrespective of a provider's qualifications or experience. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery among providers. The device is attached to a bag valve mask (i.e. manual resuscitator) and employs a flow limiting valve mechanism to minimize excessive pressure in the airway system without venting air by capping peak flow rates at 55 L/min. For an average adult with normal lung compliance and resistance, this corresponds to a maximum airway pressure of approximately 20 cmH2O which minimizes air entry into the stomach. In this superiority study, the investigators will use a two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone with respect to airway pressure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06261619
Study type	Interventional
Source	Rhode Island Hospital
Contact	Mark Kendall, MD
Phone	401-444-5172
Email	mark.kendall@lifespan.org
Status	Recruiting
Phase	N/A
Start date	February 19, 2024
Completion date	June 1, 2025

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Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms