HyPerMICROBE is a single-centre, controlled, randomised, prospective, superiority clinical trial to compare the efficacy of daily oral care with 3% hydrogen peroxide (Oroxid®) versus standard of care (0.2% chlorhexidine digluconate) on the cumulative incidence of lower respiratory tract microbial colonisation in mechanically ventilated adult critically ill patients.
Rationale: Ventilator-associated pneumonia (VAP) is the most common hospital-acquired infection (HAI) in the intensive care unit (ICU), and its impact is very high in terms of morbidity, length of hospital stay and overall costs. Chlorhexidine for oral care in critically ill has no clear impact on VAP rates and may cause harm. 3% hydrogen peroxide (Oroxid) could be a promising substitute. Aim: To test effectivity and safety of 3% hydrogen peroxide solution on ventilator-associated complications Design: Prospective, single center, parallel group randomised controlled trial. Subjects: ICU patients (general ICU) Treatment in the intervention group: daily oral care with 3% hydrogen peroxide Control group: Standard-of-care protocolised daily oral care with 0,2% chlorhexidine Primary outcome: Cumulative incidence of lower respiratory tract microbial colonisation analysed by Kaplan-Maier method, censored in the case of ICU discharge or extubation \> 24h. Secondary and exploratory outcomes: Differences in the relative risk of infection related ventilator-associated complications, antibiotic (ATB) consumption analysis, intraoral complications, reported using the Bedside oral exam (BOE) score, validated and adopted for ICU, length of ICU stay in days (time frame: at 3 months), number of ventilator-free days (time frame: at 28 days); that is, number of days, out of 28 days after admission, that patient has not been supported by mechanical ventilation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
160
All patients in experimental arm will receive usual best medical and nursing care with respect to VAP prevention including recently reviewed local "ventilator bundle "; standard microbial surveillance (tracheal aspirate) will be performed twice a week (Monday, Thursday) and always ad hoc according to the clinical situation. This reflects current practice. Daily oral care will be provided using Oroxid® mouthwash.
All patients in experimental arm will receive usual best medical and nursing care with respect to VAP prevention including recently reviewed local "ventilator bundle "; standard microbial surveillance (tracheal aspirate) will be performed twice a week (Monday, Thursday) and always ad hoc according to the clinical situation. This reflects current practice. Daily oral care will be provided using 0,2% chlorhexidine
3rd Faculty of Medicine and FNKV
Prague, Czechia
RECRUITINGCumulative incidence of lower respiratory tract microbial colonisation analysed by Kaplan-Maier method, censored in the case of ICU discharge or extubation > 24h.
To detect microorganisms in the lower respiratory tract, tracheal aspirate will be directly cultured for detecting Gram-positive, Gram-negative, and anaerobic bacteria and fungi. Standard microbial surveillance (tracheal aspirate) will be performed on admission, twice a week (Monday, Thursday) and always ad hoc according to the clinical situation.
Time frame: 18 months
Differences in the relative risk of infection related ventilator associated complications (IVAC)
According to the Centers for Disease Control and Prevention (CDC) criteria, the IVAC diagnosis will be established based on: * an increase of the daily minimum positive end-expiratory pressure (PEEP) of ≥3 cm H2O and/or the daily minimum inspired oxygen fraction (FiO2) of ≥20 points sustained for ≥2 days and * an evidence of a new infection present (abnormal temperature or white blood cell count) and prescription of a new antibiotic for ≥4 days
Time frame: 18 months
ATB exposure at discharge
Duration of antibiotics prescribed at discharge
Time frame: From the date of enrolment through to the date of ICU discharge, approximately 28 days
Intraoral complications, reported using the Bedside oral exam (BOE) score, validated and adopted for ICU.
BOE score ranges from 8 (excellent oral health) to 24 (poor oral health). The BOE scores ranging from 8-10 are considered as indicative of excellent oral health, from 11-14 as moderately impaired oral health and from 15-24 as significantly impaired oral health
Time frame: will be measured at 24 hours (T1), day 3 (T2), day 7 (T3) and day 14 (T4) after admission
Length of ICU stay in days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
that is, length of ICU stay in days
Time frame: at 3 months
Number of ventilator-free days;
that is, number of days, out of 28 days after admission, that patient has not been supported by mechanical ventilation
Time frame: at 28 days