RESUMEN
BACKGROUND: Bronchoaspiration of content that accumulates in the supraglottic area (eg, saliva, gastroesophageal reflux) is a risk factor for ventilator-associated pneumonia. A continuous supraglottic suction system may decrease the risk of bronchoaspiration in these patients. OBJECTIVE: (1) Constructing a conceptual model and functional prototype of a continuous supraglottic suction device for use in humans; (2) defining functional characteristics in ex vivo swine head models; and (3) evaluating its efficacy and safety in mechanically ventilated patients. METHODS: Study conducted in three phases. First phase: definition of distances and diameters of the triangle determined by dental arch, posterior oropharynx and vallecula, and diameter of the oropharynx in axial projection; and identification of the declining area of supraglottic suction. Second phase: design engineering and functional prototype evaluated in ex vivo models. Third phase: evaluation of device use in terms of safety and efficacy in ventilated patients. RESULTS: We obtained a final functional model of the SUPRAtube device injected into PVC for medical use. Device effectiveness in in vitro simulation showed a high and fast suction capacity of liquid and thick volumes. Study of swine heads allowed to validate the shape, size and functional fenestration of the device. Study in intubated and mechanically ventilated patients showed a high supraglottic suction capacity and the absence of local adverse events during 72 (7-240) hours of continuous operation. CONCLUSION: Our study describes the process of conceptualization, design and production of a practical, safe, low-cost continuous supraglottic suction device without representing antibiotic pressure, which appears to be a new complementary preventive strategy for the standard management of intubated and mechanically ventilated patients.
RESUMEN
Enterobacterales represent the largest group of bacterial pathogens in humans and are responsible for severe, deep-seated infections, often resulting in sepsis or death. They are also a prominent cause of multidrug-resistant (MDR) infections, and some species are recognized as biothreat pathogens. Tools for noninvasive, whole-body analysis that can localize a pathogen with specificity are needed, but no such technology currently exists. We previously demonstrated that positron emission tomography (PET) with 2-deoxy-2-[18F]fluoro-d-sorbitol (18F-FDS) can selectively detect Enterobacterales infections in murine models. Here, we demonstrate that uptake of 18F-FDS by bacteria occurs via a metabolically conserved sorbitol-specific pathway with rapid in vitro 18F-FDS uptake noted in clinical strains, including MDR isolates. Whole-body 18F-FDS PET/computerized tomography (CT) in 26 prospectively enrolled patients with either microbiologically confirmed Enterobacterales infection or other pathologies demonstrated that 18F-FDS PET/CT was safe, could rapidly detect and localize Enterobacterales infections due to drug-susceptible or MDR strains, and differentiated them from sterile inflammation or cancerous lesions. Repeat imaging in the same patients monitored antibiotic efficacy with decreases in PET signal correlating with clinical improvement. To facilitate the use of 18F-FDS, we developed a self-contained, solid-phase cartridge to rapidly (<10 min) formulate ready-to-use 18F-FDS from commercially available 2-deoxy-2-[18F]fluoro-d-glucose (18F-FDG) at room temperature. In a hamster model, 18F-FDS PET/CT also differentiated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia from secondary Klebsiella pneumoniae pneumonia-a leading cause of complications in hospitalized patients with COVID-19. These data support 18F-FDS as an innovative and readily available, pathogen-specific PET technology with clinical applications.
