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

RecruitingNAAges 18 Years - 80 YearsAllRhode Island Hospital
NCT06117683 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital. * American Society of Anesthesiologists physical status 1 and 2 Exclusion Criteria: * ASA PS \>3 (e.g., respiratory disease) * Oropharyngeal or facial pathology
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What it tests

  • ADULT Sotair Device
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Where

1 site
Rhode Island Hospital
Providence, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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