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

Not Applicable

Recruiting

• Conditions: Airway Management; Respiration, Artificial
• Interventions: Device: ADULT Sotair Device

• Registration Number: NCT06117683
• Lead Sponsor: Rhode Island Hospital

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.

Study Timeline

• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-07
• Study Start: 2023-12-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-05-28
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 310

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bag mask ventilation with Adult Sotair device	ADULT Sotair Device	The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes.

Primary Outcome Measures

Name	Time	Method
Peak airway pressure	Recorded for 3 minute duration for each arm of the study	mean peak airway pressure expressed in cm H20

Secondary Outcome Measures

Name	Time	Method
Respiratory rate	Recorded for 3 minute duration for each arm of the study	The number of breaths. Measured as breaths per minute.
Oxygen saturation (SpO2)	Recorded for 3 minute duration for each arm of the study	A present of oxygen-bound hemoglobin in the blood.
Heart rate	Recorded for 3 minute duration for each arm of the study	The number of times your heart beats per minute. Measured as beats per minute.
Airflow	Recorded for 3 minute duration for each arm of the study	Represents the volume of air moved per unit of time during inspiration and expiration. Measured s
Tidal volume	Recorded for 3 minute duration for each arm of the study	The amount of air that moves in or out of the lungs with each respiratory cycle. Measured in mL.
End Tidal CO2	Recorded for 3 minute duration for each arm of the study	The level of carbon dioxide at the end of an exhaled breath. Expressed as a percentage of CO2 or mmHg.
Blood pressure	Recorded for 3 minute duration for each arm of the study	Is the measurement of the pressure or force of blood inside your arteries. Measured as mm Hg.

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States