Safety and Efficacy of a Novel Automated Intelligent Suction Device (VapCare) Among Mechanically Ventilated Neurocritical Care Patients: A Prospective Randomized Trial.

Abstract

Background: Ventilator-associated pneumonia (VAP) is a significant concern in intensive care units (ICUs), affecting 7-32% of mechanically ventilated patients, which mounts to higher morbidity and mortality and extended hospital stays. Preventing VAP involves meticulous secretion management and oral hygiene, but in low-resource settings, VAP remains common owing to the absence of standardized oral care protocols. This randomized study assessed the efficacy and safety of the VapCare automated secretion management device in reducing microaspirations and improving clinical outcomes in ventilated patients.

Methods: A single-center, open-label randomized trial was conducted involving adult neurocritical care patients requiring mechanical ventilation for 48 h or more, excluding tracheostomized patients and patients with bleeding disorders, difficult airways, or preexisting pneumonia. Participants were randomly assigned to a control group, receiving standard ICU care with manual oropharyngeal suctioning, or a study group, receiving VapCare management. We compared lung ultrasound scores (LUS), clinical pulmonary infection scores (CPIS), secretion volumes, tracheal cultures, and chest X-ray results from day 1 to day 5.

Results: The VapCare group demonstrated a slower rise in LUS and CPIS compared to the control group. The median CPIS rose from 1 (interquartile range [IQR] 1-2) on the first day to 5 (IQR 2.75-6) on the fifth day in the control group versus 1 (IQR 0-2) on the first day to 3 (IQR 2-3) on the fifth day in the VapCare group (p < 0.001). The median LUS increased from 0 (IQR 0-2) on the first day to 6 (IQR 2-10) on the fifth in the control group, whereas the change was more muted in the VapCare group (0 [IQR 1-2] on the first day to 4 [IQR 2-6] on the fifth day [p < 0.001]). Additionally, chest X-ray scores were lower in the VapCare group (p = 0.028). Tracheal culture microbial growth and mortality were similar in both groups, but the length of ICU stay was significantly shorter in the VapCare group (p = 0.004). One patient in the VapCare group sustained mucosal erosions on the lip due to the VapCare mouthpiece.

Conclusions: The VapCare device effectively reduces microaspiration and mitigates lung changes, demonstrating its potential to reduce the burden of microaspiration and suctioning in ventilated patients.