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

Last updated: June 30, 2025
Sponsor: Rhode Island Hospital
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Adult Sotair Device

Clinical Study ID

NCT06261619
2079951
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

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

  • Oropharyngeal or facial pathology

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Adult Sotair Device
Phase:
Study Start date:
May 09, 2024
Estimated Completion Date:
March 18, 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 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.

Connect with a study center

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.