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

Lifespan

Status: Completed

Conditions: Respiration, Artificial; Airway Management

Treatments: Device: Adult Sotair Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06261619

2079951

Details and patient eligibility

About

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.

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 superiority study, 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.

Enrollment: 30 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 (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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 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 with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds.

Treatment:

Device: Adult Sotair Device

Bag mask ventilation

No Intervention group

Description:

The anesthesia provider will manually bag ventilate for 3 minutes with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds.