Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation

Non-inferiority Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation in Patients Undergoing Non-emergent Surgery With General Anesthesia

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.

Study Overview

• Status: Recruiting
• Conditions: Airway Management; Respiration, Artificial
• Intervention / Treatment: Device: ADULT Sotair Device

Detailed 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 non-inferiority study, a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation with respect to airway pressure.

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Farias; Phone Number: 401-444-5172; Email: stephanie.farias@lifespan.org
• Study Contact Backup: Name: Mark Brady, MD; Email: mark.brady@brownphysicians.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
      • Contact: Mark Kendall, MD; Phone Number: 401-444-5172; Email: mark.kendall@lifespan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bag mask ventilation with Adult Sotair device; The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes.	Device: ADULT Sotair Device; Sotair® device employs a flow limiting and pressure control valve mechanism.; Other Names: Sotair; SafeBVM
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak airway pressure	mean peak airway pressure expressed in cm H20	Recorded for 3 minute duration for each arm of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal volume	The amount of air that moves in or out of the lungs with each respiratory cycle. Measured in mL.	Recorded for 3 minute duration for each arm of the study
Airflow	Represents the volume of air moved per unit of time during inspiration and expiration. Measured s	Recorded for 3 minute duration for each arm of the study
Respiratory rate	The number of breaths. Measured as breaths per minute.	Recorded for 3 minute duration for each arm of the study
Oxygen saturation (SpO2)	A present of oxygen-bound hemoglobin in the blood.	Recorded for 3 minute duration for each arm of the study
End Tidal CO2	The level of carbon dioxide at the end of an exhaled breath. Expressed as a percentage of CO2 or mmHg.	Recorded for 3 minute duration for each arm of the study
Blood pressure	Is the measurement of the pressure or force of blood inside your arteries. Measured as mm Hg.	Recorded for 3 minute duration for each arm of the study
Heart rate	The number of times your heart beats per minute. Measured as beats per minute.	Recorded for 3 minute duration for each arm of the study

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Investigators: Principal Investigator: Mark Kendall, MD, Rhode Island Hospital

Publications and helpful links

General Publications

• Fogarty M, Kuck K, Orr J, Sakata D. A comparison of controlled ventilation with a noninvasive ventilator versus traditional mask ventilation. J Clin Monit Comput. 2020 Aug;34(4):771-777. doi: 10.1007/s10877-019-00365-1. Epub 2019 Jul 23.
• von Goedecke A, Bowden K, Wenzel V, Keller C, Gabrielli A. Effects of decreasing inspiratory times during simulated bag-valve-mask ventilation. Resuscitation. 2005 Mar;64(3):321-5. doi: 10.1016/j.resuscitation.2004.09.003.
• Culbreth RE, Gardenhire DS. Manual bag valve mask ventilation performance among respiratory therapists. Heart Lung. 2021 May-Jun;50(3):471-475. doi: 10.1016/j.hrtlng.2020.10.012. Epub 2020 Nov 1.
• Hutten MC, Goos TG, Ophelders D, Nikiforou M, Kuypers E, Willems M, Niemarkt HJ, Dankelman J, Andriessen P, Mohns T, Reiss IK, Kramer BW. Fully automated predictive intelligent control of oxygenation (PRICO) in resuscitation and ventilation of preterm lambs. Pediatr Res. 2015 Dec;78(6):657-63. doi: 10.1038/pr.2015.158. Epub 2015 Aug 31.

Helpful Links

• Adult Sotair Products

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; General Anesthesia; Bag Mask Ventilation; Adult Sotair Device
• Other Study ID Numbers: 1963885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD that underlie results in a publication will be shared with other researchers.
• IPD Sharing Time Frame: The SAP will be available at the end of the trial for three years. The data that supports the findings of this study will be available from the corresponding investigator upon reasonable request.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No