Superiority Trial Between Sotair® Device Attached to Manual Resuscitator

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06261619
Study type	Interventional
Source	Rhode Island Hospital
Contact	Mark Kendall, MD
Phone	401-444-5172
Email	mark.kendall@lifespan.org
Status	Recruiting
Phase	N/A
Start date	February 19, 2024
Completion date	June 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03908411` - The Effect of Paratracheal Pressure on the Glottic View	N/A
Completed	`NCT04564105` - Simulation Training and Teamwork Concerning Intubation on the Icu	N/A
Completed	`NCT02988336` - TMHT - New Method of Difficult Intubation Prediction	N/A
Completed	`NCT03002857` - Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery	N/A
Recruiting	`NCT06337006` - Laryngeal Mask Airway Failure in Pediatric Patients
Completed	`NCT03443219` - RCT- LMA Supreme™ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients	N/A
Completed	`NCT05044416` - VieScope in Patients With an Expected Difficult Airway	N/A
Not yet recruiting	`NCT05534451` - Comparison Among Three Different Video Scope Guided Nasotracheal Intubation.	N/A
Recruiting	`NCT06073977` - Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation
Not yet recruiting	`NCT03687385` - The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients	N/A
Not yet recruiting	`NCT03687424` - Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults?	N/A
Enrolling by invitation	`NCT05055401` - Airway Management Skills Amongst Anesthesia Providers
Terminated	`NCT02644837` - AuraGain and iGel Crossover Comparison	N/A
Not yet recruiting	`NCT02920879` - Airway Effects of PEEP During Anesthesia Induction.	N/A
Completed	`NCT02263300` - Spatial Orientation and Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
Completed	`NCT01718561` - The Difficult Airway Management Trial: "The DIFFICAIR-Trial"	N/A
Completed	`NCT01635660` - Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation	N/A
Completed	`NCT00956592` - Clinical Evaluation of the Storz CMAC Laryngoscope	N/A
Completed	`NCT00892671` - Airway Management and Vascular Access Simulation	N/A
Completed	`NCT03848559` - Airway Management With Simulated Microgravity Using a Submerged Model	N/A

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms