Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone

Not Applicable

Recruiting

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

• Registration Number: NCT06261619
• Lead Sponsor: Rhode Island Hospital

Brief Summary

Effective respiratory ventilation is achieved by moving the right amount of air to 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 superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.

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 superiority study, the investigators will use a two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone with respect to airway pressure.

Study Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Study Start: 2024-05-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adult patients who are scheduled for non-emergency surgery with general anesthesia (w/artificial airway) at Rhode Island Hospital.
• American Society Of Anesthesiologists Physical Status 1 and 2

Exclusion Criteria

• American Society of Anesthesiologists Physical Status >3 (e.g. respiratory disease)
• Oropharyngeal or facial pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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 with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds.

Primary Outcome Measures

Name	Time	Method
Peak airway pressure	Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study	Mean of the maximum peak airway pressures expressed in cm H2O

Secondary Outcome Measures

Name	Time	Method
Airflow	Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study	Represents the volume of air moved per unit of time during inspiration and expiration. Measured (L/min)
Tidal volume	Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study	The amount of air that moves to or out of the lungs with each respiratory cycle. Measured in mL. Mean of the maximum tidal volumes every 30 seconds.

Trial Locations

Locations (1)

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