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

NCT06117683 | Recruiting FDA Device

• 1 other identifier: 1963885
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Peak airway pressure

  mean peak airway pressure expressed in cm H20

  Recorded for 3 minute duration for each arm of the study

Secondary Outcomes (7)

• Tidal volume

  Recorded for 3 minute duration for each arm of the study

• Airflow

  Recorded for 3 minute duration for each arm of the study

• Respiratory rate

  Recorded for 3 minute duration for each arm of the study

• Oxygen saturation (SpO2)

  Recorded for 3 minute duration for each arm of the study

• End Tidal CO2

  Recorded for 3 minute duration for each arm of the study

Study Arms (2)

Bag mask ventilation with Adult Sotair device

ACTIVE COMPARATOR

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

Device: ADULT Sotair Device

Mechanical Ventilation

NO INTERVENTION

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 DEVICE

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

Also known as: Sotair, SafeBVM

Bag mask ventilation with Adult Sotair device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ASA PS \>3 (e.g., respiratory disease)
• Oropharyngeal or facial pathology

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 31338661 BACKGROUND

• 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.

  PMID: 15733761 BACKGROUND

• 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.

  PMID: 33138977 BACKGROUND

• 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.

  PMID: 26322409 BACKGROUND

Related Links

• Adult Sotair Products

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Kendall, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Farias

CONTACT

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

Mark Brady, MD

CONTACT

mark.brady@brownphysicians.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The care provider will not know the recorded lung function recordings.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Model Details: Study Design A non-inferiority trial; a pre-post study design (single group, within-group comparison)

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: December 20, 2023
• Primary Completion: June 30, 2025
• Study Completion: July 1, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• 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.

Locations

US (1)