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

Completed · Not applicable

Conditions studied: Airway Management, Respiration, Artificial

In brief

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.

Key facts

Study ID

NCT06261619

Run by

Rhode Island Hospital

People needed

30

Starts

2024-05-09

Expected to finish

2025-03-18

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients who are scheduled for non-emergency surgery with general anesthesia (w/artificial airway) at Rhode Island Hospital.
• American Society Of Anesthesiologists Physical Status 1 and 2

You may not qualify if…

• American Society of Anesthesiologists Physical Status >3 (e.g. respiratory disease)
• Oropharyngeal or facial pathology

Where it is running

• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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