RecruitingPhase 4NCT06045429

Oral Care With 3% Hydrogen Peroxide (Oroxid®) in ICU - Effects on the Lower Airway Microbial Colonisation

Effects of Oral Care With 3% Hydrogen Peroxide (Oroxid®) on the Lower Respiratory Tract Microbial Colonisation in Mechanically Ventilated Adult Critically Ill Patients (HyPer-MICROBE Trial); a Single-centre, Randomised, Controlled Trial


Sponsor

Charles University, Czech Republic

Enrollment

160 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Age ≥18 years
  • In-patient of ICU and expected to stay \> 5 days
  • Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation (MV) ≥ 72h
  • Clinical Pulmonary Infection score (CPIS) less than 6 at the baseline
  • No history and symptoms of aspiration at the baseline

Exclusion Criteria5

  • ATB therapy of respiratory infection on admission
  • Suspected pulmonary infection on admission and in the first 48h of mechanical ventilation
  • Pregnancy
  • Oral ulcers or injuries
  • Patient with a history of hydrogen peroxide allergy

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Interventions

DRUGOroxid®

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.

DRUGChlorhexidine 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


Locations(1)

3rd Faculty of Medicine and FNKV

Prague, Czechia

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NCT06045429


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