Recruiting

Sotair® & Mechanical Ventilation

Sponsor:

Rhode Island Hospital

Code:

NCT06117683

Conditions

Airway Management

Respiration, Artificial

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ADULT Sotair Device

Study Details

Brief summary:

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.

Conditions

Airway Management

Respiration, Artificial

Study ID

NCT06117683

Start date

Dec 20, 2023

Status verified date

Jul, 2025

Completion date

Jul, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

310 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Bag mask ventilation with Adult Sotair device

The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes.

no intervention: Mechanical Ventilation

The anesthesia provider will remove the bag valve mask and Adult Sotair® device and connect the patient to the mechanical ventilator. The recording of pressure and flow will last for 3 minutes.

Interventions

ADULT Sotair Device

Sotair® device employs a flow limiting and pressure control valve mechanism.

Primary outcome measure

  • Peak airway pressure [ Time Frame: Recorded for 3 minute duration for each arm of the study ]

Central Contacts and Locations

Central contacts

Stephanie Farias

401-444-5172stephanie.farias@lifespan.org

Mark Brady, MD

mark.brady@brownphysicians.org

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Mark Kendall, MD

401-444-5172mark.kendall@lifespan.org

More Information

Sponsor

Rhode Island Hospital

Last update posted

Jul 11, 2025

Last verified

Jul, 2025

Keywords

  • Mechanical Ventilation
  • General Anesthesia
  • Bag Mask Ventilation
  • Adult Sotair Device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2025-07-11.