Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation

Airway Management Clinical Trial

Official title:

Non-inferiority Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation in Patients Undergoing Non-emergent Surgery With General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117683
• Other study ID #: 1963885
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: Rhode Island Hospital
• Contact: Stephanie Farias
• Phone: 401-444-5172
• Email: stephanie.farias[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: January 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Management
• Respiration, Artificial

Intervention

Device:
• ADULT Sotair Device
Sotair® device employs a flow limiting and pressure control valve mechanism.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak airway pressure	mean peak airway pressure expressed in cm H20	Recorded for 3 minute duration for each arm of the study
Secondary	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
Secondary	Airflow	Represents the volume of air moved per unit of time during inspiration and expiration. Measured s	Recorded for 3 minute duration for each arm of the study
Secondary	Respiratory rate	The number of breaths. Measured as breaths per minute.	Recorded for 3 minute duration for each arm of the study
Secondary	Oxygen saturation (SpO2)	A present of oxygen-bound hemoglobin in the blood.	Recorded for 3 minute duration for each arm of the study
Secondary	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
Secondary	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
Secondary	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

External Links

•   Adult Sotair Products