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NCT Number: NCT06117683

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

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.

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Key information

Conditions

Airway Management Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiration, Artificial Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location status: Recruiting

Location contact

Mark Kendall, MD

CONTACT

[email protected]

401-444-5172

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADULT Sotair Device

Device

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

Other names: Sotair, SafeBVM

Primary outcomes

  1. Peak airway pressure

    Time frame: Recorded for 3 minute duration for each arm of the study

    mean peak airway pressure expressed in cm H20

Secondary outcomes

  1. Tidal volume

    Time frame: Recorded for 3 minute duration for each arm of the study

    The amount of air that moves in or out of the lungs with each respiratory cycle. Measured in mL.

  2. Airflow

    Time frame: Recorded for 3 minute duration for each arm of the study

    Represents the volume of air moved per unit of time during inspiration and expiration. Measured s

  3. Respiratory rate

    Time frame: Recorded for 3 minute duration for each arm of the study

    The number of breaths. Measured as breaths per minute.

  4. Oxygen saturation (SpO2)

    Time frame: Recorded for 3 minute duration for each arm of the study

    A present of oxygen-bound hemoglobin in the blood.

  5. End Tidal CO2

    Time frame: Recorded for 3 minute duration for each arm of the study

    The level of carbon dioxide at the end of an exhaled breath. Expressed as a percentage of CO2 or mmHg.

  6. Blood pressure

    Time frame: Recorded for 3 minute duration for each arm of the study

    Is the measurement of the pressure or force of blood inside your arteries. Measured as mm Hg.

  7. Heart rate

    Time frame: Recorded for 3 minute duration for each arm of the study

    The number of times your heart beats per minute. Measured as beats per minute.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Brady, MD

CONTACT

[email protected]

Stephanie Farias

CONTACT

[email protected]

401-444-5172

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2023
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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