Clinical trial NCT06117683: Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Airway Management
Respiration, Artificial
Keywords: Mechanical Ventilation
General Anesthesia
Bag Mask Ventilation
Adult Sotair Device
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Study Design A non-inferiority trial; a pre-post study design (single group, within-group comparison)
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak airway pressure
timeFrame: Recorded for 3 minute duration for each arm of the study
Secondary outcomes:
measure: Tidal volume
timeFrame: Recorded for 3 minute duration for each arm of the study
measure: Airflow
timeFrame: Recorded for 3 minute duration for each arm of the study
measure: Respiratory rate
timeFrame: Recorded for 3 minute duration for each arm of the study
measure: Oxygen saturation (SpO2)
timeFrame: Recorded for 3 minute duration for each arm of the study
measure: End Tidal CO2
timeFrame: Recorded for 3 minute duration for each arm of the study
measure: Blood pressure
timeFrame: Recorded for 3 minute duration for each arm of the study
measure: Heart rate
timeFrame: Recorded for 3 minute duration for each arm of the study
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Mark Kendall, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
citation: 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.
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