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

Map preview placeholder

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.