Qualitative Investigation of EMS Provider Experiences with a Flow-Regulating Safety Device for Manual Ventilation A Preliminary Report

Abstract

Background: Over-ventilation during bag-valve-mask (BVM) ventilation (and manual ventilation in general) is a well-documented hazard in prehospital emergency care. It is associated with increased intrathoracic pressure, reduced cardiac output, gastric insufflation, and decreased survival in cardiac arrest and traumatic brain injury. The Sotair® (SafeBVM Corp., Boston, MA), is a flow-regulating safety device (FRSD) designed to prevent over-ventilation by limiting tidal volume during manual ventilation. Despite its potential clinical utility, provider-level experiences with the device in the real-world EMS clinical settings remain unreported.

Objective: We sought to explore experiences of EMS providers using the Sotair® device in clinical and training settings, with attention to perceived usability, clinical outcomes, barriers to consistent use, and recommendations for improvement.

Methods: Seven semi-structured interviews were conducted with EMS providers (EMTs, paramedics, training officers, and rescue chiefs) who have used the FRSD clinically. Interviews were analyzed using standard rapid thematic analysis. Thematic saturation was assessed iteratively and confirmed by convergence across all seven interviews.

Results: Six themes emerged: (1) Device Understanding and Simplicity: all participants described the device as intuitive, and required minimal training; (2) Training Value: the device demonstrated unexpected utility as a training instrument, with novice providers who trained with the device outperformed experienced peers on a ventilation feedback platform, with retained technique after device removal; (3) Clinical Experiences: primary use was cardiac arrest; participants reported anecdotal improvements in ROSC rates and reductions in gastric insufflation; (4) Cognitive Load Reduction and Anxiety Management: participants described reduced mental burden during resuscitation, freeing attention for scene management; (5) Barriers to Consistent Use: forgetting to deploy the device, resistance from experienced providers, cost concerns, and uncertainty in specific clinical scenarios (head trauma, drowning, pediatric patients) were identified; (6) Recommendations: pre-integration with BVM was endorsed by all participants; additional recommendations included a pediatric version, peer-to-peer marketing, and usage tracking research.

Conclusions: EMS providers reported favorable experiences with the FRSD across clinical and training contexts. The device’s simplicity, cognitive load benefits, and emergent value as a training tool suggests both direct clinical and educational applications. Barriers to adoption, most notably forgetting to deploy, may be addressable through pre-implementation with standard BVM equipment.