Airway Management, Respiration, Artificial
Conditions
Keywords
Mechanical Ventilation, General Anesthesia, Bag Mask Ventilation, Adult Sotair Device
Brief summary
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.
Detailed 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 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.
Interventions
DEVICEAdult Sotair Device
Adult Sotair® device employs a flow limiting valve mechanism.
Sponsors
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
The care provider will not know the recorded lung function recordings.
Intervention model description
Study Design: A superiority trial; a single two-group cross over randomized trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak airway pressure | 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
| Measure | Time frame | Description |
|---|---|---|
| Tidal volume | 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. |
| Airflow | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark Kendall, MD
Rhode Island Hospital
Outcome results
None listed