Investigators in Vietnam found that maintenance of continuous endotracheal cuff pressure control (CPC) via an automated electronic device was not effective in reducing the incidence of ventilator-associated respiratory infections (VARIs) compared with standard of care. Findings of this multicenter, open-label, randomized, controlled trial (ClinicalTrials.gov identifier: NCT02966392) were recently published in the journal Clinical Infectious Diseases.
The researchers studied patients from 3 Vietnamese intensive care units (ICUs) within 24 hours of intubation to assess whether the use of continuous CPC is linked to a decreased rate of VARIs compared with the utilization of intermittent CPC. Study participants were randomly assigned in a 1:1 ratio to receive either continuous CPC via an automated electronic device or intermittent CPC via a manually hand-held manometer.
The primary study endpoint was the percentage of patients with1 or more VARI episode during their ICU stay. Secondary endpoints included microbiologically confirmed VARI and ventilator-associated pneumonia, duration of mechanical ventilation/intubation, intubated days during which systemic antimicrobial agents were administered, length and cost of ICU/hospital stay, rates of other hospital-acquired infections, costs of antimicrobials during ICU/hospital stay, and mortality at 28 days and 90 days.
From November 2016 through December 2018, a total of 297 participants were randomized to receive continuous CPC and 303 to receive intermittent CPC. Of the 600 patients, 3 did not receive the allocated intervention (1 in the continuous CPC group and 2 in the intermittent CPC group) and were not included in the intention-to-treat (ITT) analysis. Thus, the ITT population comprised 296 participants in the continuous CPC arm and 301 in the intermittent CPC arm. The last study follow-up was conducted in March 2019. Overall, 69.2% (413 of 497) of the participants were male. A total of 25.6% (153 of 597) of patients were initially ventilated by tracheostomy.
The use of continuous CPC, compared with intermittent CPC, was not associated with a significant reduction in the percentage of patients with 1 or more episode of VARI (25% [74 of 296] vs 23% [69 of 301], respectively; odds ratio [OR], 1.13; 95% CI, 0.77-1.67).
No statistically significant differences between continuous CPC and intermittent CPC were reported with respect to the proportion of microbiologically confirmed VARIs (OR, 1.40; 95% CI, 0.94-2.10); the percentage of intubated days without antimicrobial use (relative proportion, 0.99; 95% CI, 0.87-1.12); the rate of ICU discharge (cause-specific hazard ratio, 0.95; 95% CI, 0.78-1.16); cost of ICU stay (difference in transformed mean [DTM], 0.02; 95% CI, -0.05 to -0.08); cost of antimicrobial agents during ICU stay (DTM, 0.02; 95% CI, -0.25 to 0.28); cost of hospitalization (DTM, 0.02; 95% CI, -0.04 to 0.08); and ICU mortality risk (OR, 0.96; 95% CI, 0.67-1.38).
The researchers concluded that in this Vietnamese study, rates of VARI were not reduced when CPC was maintained via the use of an automated electronic device vs via use of intermittent CPC. However, researchers further noted that interventions demonstrating benefit in high-income countries do not necessarily demonstrate similar benefit in low- to middle-income countries (LMICs) such as Vietnam.
Dat VQ, Yen LM, Loan HT, et al. Effectiveness of continuous endotracheal cuff pressure control for the prevention of ventilator associated respiratory infections: an open-label randomised, controlled trial. Clin Infect Dis. Published online August 22, 2021.doi:10.1093/cid/ciab724