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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bag mask ventilation with Adult Sotair device | Active Comparator | The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes. |
|
| Mechanical Ventilation | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADULT Sotair Device | Device | Sotair® device employs a flow limiting and pressure control valve mechanism. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak airway pressure | mean peak airway pressure expressed in cm H20 | Recorded for 3 minute duration for each arm of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Tidal volume | The amount of air that moves in or out of the lungs with each respiratory cycle. Measured in mL. | Recorded for 3 minute duration for each arm of the study |
| Airflow | Represents the volume of air moved per unit of time during inspiration and expiration. Measured s |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Farias | Contact | 401-444-5172 | stephanie.farias@lifespan.org | |
| Mark Brady, MD | Contact | mark.brady@brownphysicians.org |
| Name | Affiliation | Role |
|---|---|---|
| Mark Kendall, MD | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31338661 | Background | Fogarty M, Kuck K, Orr J, Sakata D. A comparison of controlled ventilation with a noninvasive ventilator versus traditional mask ventilation. J Clin Monit Comput. 2020 Aug;34(4):771-777. doi: 10.1007/s10877-019-00365-1. Epub 2019 Jul 23. | |
| 15733761 | Background | von Goedecke A, Bowden K, Wenzel V, Keller C, Gabrielli A. Effects of decreasing inspiratory times during simulated bag-valve-mask ventilation. Resuscitation. 2005 Mar;64(3):321-5. doi: 10.1016/j.resuscitation.2004.09.003. |
| Label | URL |
|---|---|
| Adult Sotair Products | View source |
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The IPD that underlie results in a publication will be shared with other researchers.
The SAP will be available at the end of the trial for three years. The data that supports the findings of this study will be available from the corresponding investigator upon reasonable request.
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Study Design A non-inferiority trial; a pre-post study design (single group, within-group comparison)
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The care provider will not know the recorded lung function recordings.
| Recorded for 3 minute duration for each arm of the study |
| Respiratory rate | The number of breaths. Measured as breaths per minute. | Recorded for 3 minute duration for each arm of the study |
| Oxygen saturation (SpO2) | A present of oxygen-bound hemoglobin in the blood. | Recorded for 3 minute duration for each arm of the study |
| End Tidal CO2 | The level of carbon dioxide at the end of an exhaled breath. Expressed as a percentage of CO2 or mmHg. | Recorded for 3 minute duration for each arm of the study |
| Blood pressure | Is the measurement of the pressure or force of blood inside your arteries. Measured as mm Hg. | Recorded for 3 minute duration for each arm of the study |
| Heart rate | The number of times your heart beats per minute. Measured as beats per minute. | Recorded for 3 minute duration for each arm of the study |
| 33138977 | Background | Culbreth RE, Gardenhire DS. Manual bag valve mask ventilation performance among respiratory therapists. Heart Lung. 2021 May-Jun;50(3):471-475. doi: 10.1016/j.hrtlng.2020.10.012. Epub 2020 Nov 1. |
| 26322409 | Background | Hutten MC, Goos TG, Ophelders D, Nikiforou M, Kuypers E, Willems M, Niemarkt HJ, Dankelman J, Andriessen P, Mohns T, Reiss IK, Kramer BW. Fully automated predictive intelligent control of oxygenation (PRICO) in resuscitation and ventilation of preterm lambs. Pediatr Res. 2015 Dec;78(6):657-63. doi: 10.1038/pr.2015.158. Epub 2015 Aug 31. |