Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation

Phase

N/A

Condition

N/A

Treatment

ADULT Sotair Device

Clinical Study ID

NCT06117683

1963885

Ages 18-80
All Genders

Study Summary

Effective respiratory ventilation is achieved by moving the right amount of air in 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 non-inferiority study, we will perform a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adult patients who are scheduled for non-emergency surgery with general anesthesiaat Rhode Island Hospital.
American Society of Anesthesiologists physical status 1 and 2

Exclusion

Exclusion Criteria:

ASA PS >3 (e.g., respiratory disease)
Oropharyngeal or facial pathology

Study Design

ADULT Sotair Device

December 20, 2023

May 28, 2025

Study 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 non-inferiority study, a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation with respect to airway pressure.

Connect with a study center

Rhode Island Hospital
Providence, Rhode Island 02903
United States
Site Not Available

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