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

Study Overview
=================
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.

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

Conditions
-----------------
Airway Management, Respiration, Artificial

Intervention / Treatment
-----------------
* Device: ADULT Sotair Device


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Study Design A non-inferiority trial; a pre-post study design (single group, within-group comparison)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bag mask ventilation with Adult Sotair device<br>The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes. | Device: ADULT Sotair Device<br>* Sotair® device employs a flow limiting and pressure control valve mechanism.<br>* Other names: SafeBVM;|
| No Intervention: Mechanical Ventilation<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak airway pressure | mean peak airway pressure expressed in cm H20 | Recorded for 3 minute duration for each arm of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Respiratory rate | The number of breaths. Measured as breaths per minute. | Recorded for 3 minute duration for each arm of the study | 
| Oxygen saturation (SpO2) | A present of oxygen-bound hemoglobin in the blood. | Recorded for 3 minute duration for each arm of the study | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mechanical Ventilation, General Anesthesia, Bag Mask Ventilation, Adult Sotair Device