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Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation | ClinicalTrials.gov NCT06117683

  • September 30, 2026
  • Prathamesh
ClinicalTrials.gov record NCT06117683, Sotair non-inferiority trial versus mechanical ventilation, status recruiting
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ClinicalTrials.govNCT06117683Recruiting

Registry Record

View on ClinicalTrials.gov · NCT06117683 →

Study at a Glance

  • Registered title: Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
  • Sponsor: Rhode Island Hospital
  • Population: Adults having non-emergent surgery under general anesthesia
  • Design (per registry): Single-group, within-group comparison of manual ventilation with Sotair® and mechanical ventilation
  • Primary outcome: Peak airway pressure
  • Registry status: Recruiting

Results

Not yet published. When results are published, a summary will be added to the Papers section.

Details are shown as listed on ClinicalTrials.gov (last update posted 2025-07-11). See the registry record for the current status.

Sotair® is FDA 510(k) cleared (K212905) for use in non-breathing adults and is intended to minimize gastric inflation during manual ventilation. Refer to the Instructions for Use for indications, contraindications, warnings and precautions. SotairIQ™ is for training and education use only. This page lists a registered study for healthcare professionals. The registry record is the authoritative source for study details.