Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Bag mask ventilation with Adult Sotair device The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes. |
Device: ADULT Sotair Device
Sotair® device employs a flow limiting and pressure control valve mechanism.
Other Names:
|
| No Intervention: Mechanical Ventilation 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. |
Outcome Measures
Primary Outcome Measures
- Peak airway pressure [3 minutes for each arm of the study]
mean peak airway pressure expressed in cm H20
Secondary Outcome Measures
- Tidal volume [3 minutes 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.
- Airflow [3 minutes for each arm of the study]
Represents the volume of air moved per unit of time during inspiration and expiration. Measured s
- Respiratory rate [3 minutes for each arm of the study]
The number of breaths. Measured as breaths per minute.
- Oxygen saturation (SpO2) [3 minutes for each arm of the study]
A present of oxygen-bound hemoglobin in the blood.
- End Tidal CO2 [3 minutes 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.
- Blood pressure [3 minutes 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 [3 minutes for each arm of the study]
The number of times your heart beats per minute. Measured as beats per minute.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital.
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American Society of Anesthesiologists physical status 1 and 2
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A score of ≤ 2 out of 5 using the difficult mask ventilation criteria as described by Langeron et al.
Exclusion Criteria:
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ASA PS >3 (e.g., respiratory disease)
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Oropharyngeal or facial pathology
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
Sponsors and Collaborators
- Rhode Island Hospital
Investigators
- Principal Investigator: Mark Kendall, MD, Rhode Island Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
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