Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone

Airway Management Clinical Trial

Official title:

A Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Manual Ventilation Alone in Patients Undergoing Non-emergent Surgery With General Anesthesia: A Prospective Randomized Cross-over Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261619
• Other study ID #: 2079951
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: Rhode Island Hospital
• Contact: Mark Kendall, MD
• Phone: 401-444-5172
• Email: mark.kendall[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 superiority study, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2025
• Est. primary completion date: January 31, 2025
• 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 (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

Related Conditions & MeSH terms

• Airway Management
• Respiration, Artificial

Intervention

Device:
• Adult Sotair Device
Adult Sotair® device employs a flow limiting 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 (3)

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

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 of the maximum peak airway pressures expressed in cm H2O	Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study
Secondary	Tidal volume	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.	Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study
Secondary	Airflow	Represents the volume of air moved per unit of time during inspiration and expiration. Measured (L/min)	Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study

External Links

•   Adult Sotair Products