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 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.
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 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.
Interventions
DEVICEADULT Sotair Device
Sotair® device employs a flow limiting and pressure control valve mechanism.
Sponsors
Rhode Island Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
The care provider will not know the recorded lung function recordings.
Intervention model description
Study Design A non-inferiority trial; a pre-post study design (single group, within-group comparison)
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak airway pressure | Recorded for 3 minute duration for each arm of the study | mean peak airway pressure expressed in cm H20 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Airflow | 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 |
| Respiratory rate | Recorded for 3 minute duration for each arm of the study | The number of breaths. Measured as breaths per minute. |
| Oxygen saturation (SpO2) | Recorded for 3 minute duration for each arm of the study | A present of oxygen-bound hemoglobin in the blood. |
| Tidal volume | 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. |
| Blood pressure | 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. |
| Heart rate | 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. |
| End Tidal CO2 | 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. |
Countries
United States
Contacts
Primary ContactStephanie Farias
Backup ContactMark Brady, MD
Outcome results
None listed