Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRhode Island Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
ASA PS >3 (e.g., respiratory disease)
Oropharyngeal or facial pathology
Trial design
Design model
Single group
Treatments tested in this trial
ADULT Sotair Device
DeviceSotair® device employs a flow limiting and pressure control valve mechanism.
Treatment groups
310 Participants
are divided into 2 treatment groupsGroup A: Bag mask ventilation with Adult Sotair deviceActive comparator 1 intervention
Group B: Mechanical VentilationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Peak airway pressure
mean peak airway pressure expressed in cm H20
Time frame
Recorded for 3 minute duration for each arm of the studySecondary outcomes
1
Tidal volume
The amount of air that moves in or out of the lungs with each respiratory cycle. Measured in mL.
Time frame
Recorded for 3 minute duration for each arm of the study2
Airflow
Represents the volume of air moved per unit of time during inspiration and expiration. Measured s
Time frame
Recorded for 3 minute duration for each arm of the study3
Respiratory rate
The number of breaths. Measured as breaths per minute.
Time frame
Recorded for 3 minute duration for each arm of the study4
Oxygen saturation (SpO2)
A present of oxygen-bound hemoglobin in the blood.
Time frame
Recorded for 3 minute duration for each arm of the studySponsors and contacts
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Source ClinicalTrials.gov