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

Lifespan

Status: Enrolling

Conditions: Respiration, Artificial; Airway Management

Treatments: Device: ADULT Sotair Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06117683

1963885

Details and patient eligibility

About

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.

Full 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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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310 participants in 2 patient groups

Bag mask ventilation with Adult Sotair device

Active Comparator group

Description:

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

Treatment:

Device: ADULT Sotair Device

Mechanical Ventilation

No Intervention group

Description:

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.