Routine (7 days) vs. clinically indicated change of the noninvasive ventilator circuit for prevention of hospital-acquired pneumonia: Protocol for a randomized controlled trial in 2 tertiary hospitals

Abstract

Abstract Background The change frequency of the ventilator circuit was once thought to be the main cause of ventilator-associated pneumonia (VAP), but recent evidence has shown that it is not strongly relevant to VAP in invasively ventilated patients. However, circuits of noninvasive positive pressure ventilation (NPPV) are still routinely (every 7 days) changed in many hospitals to prevent hospital-acquired pneumonia (HAP) without evidence, which is a heavy economic burden on the health system. Methods This is a nonblinded, prospective, randomized controlled multicenter trial. Patients who receive NPPV onset in this hospitalization will be screened for eligibility. A total of 340 eligible participants will be stratified (3:2) in two research sites and will be randomly allocated to routine changes in the ventilator circuit group or clinically indicated changes in the circuit group at a ratio of 1:1. Routine prevention for HAP will be provided in both groups. The primary outcome is the occurrence of HAP 48 hrs after NPPV therapy starts or 48 hrs within weaning from NPPV. Secondary outcomes include the length of hospital stay, length of each circuit duration, NPPV treatment days, intubation, mortality and direct cost of the circuits and antibiotics. The growth curve of microorganisms in the ventilator circuit will also be analyzed. It is hypothesized that there will be no difference in the occurrence of HAP in the two arms. Furthermore, a decrease in circuit cost is expected in the intervention group, and the microorganisms in the ventilator circuit are predicted to not increase over time. Discussion NPPVs are widely used in patients with various diseases from different healthcare settings. Evidence-based rules for changing NPPV circuits are limited. If supported, our pioneer study will provide a cost-effective NPPV management method without increasing the risks of HAP.