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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06117683
Other study ID # 1963885
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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