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Completed

NCT Number: NCT06261619

Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone

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.

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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

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 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 (margin 7.5 cm H20), 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.

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 (w/artificial airway) at Rhode Island Hospital.
  • American Society Of Anesthesiologists Physical Status 1 and 2

Exclusion criteria

  • American Society of Anesthesiologists Physical Status >3 (e.g. respiratory disease)
  • Oropharyngeal or facial pathology

Treatment and study plan

ADULT Sotair Device

Device

Adult Sotair® device employs a flow limiting valve mechanism.

Other names: Sotair, SafeBVM

Primary outcomes

  1. Peak airway pressure

    Time frame: Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study

    Mean of the maximum peak airway pressures expressed in cm H2O

Secondary outcomes

  1. Tidal volume

    Time frame: Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study

    The amount of air that moves to or out of the lungs with each respiratory cycle. Measured in mL. Mean of the maximum tidal volumes every 30 seconds.

  2. Airflow

    Time frame: Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study

    Represents the volume of air moved per unit of time during inspiration and expiration. Measured (L/min)

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Registry information

Official study title

A Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Manual Ventilation Alone in Patients Undergoing Non-emergent Surgery With General Anesthesia: A Prospective Randomized Cross-over Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2024
Registry last updated
Jul 21, 2026

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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