Status:

RECRUITING

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

Lead Sponsor:

Charles University, Czech Republic

Conditions:

VAP - Ventilator Associated Pneumonia

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 ...

Detailed Description

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 hos...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

160 Patients enrolled

Trial Details

Trial ID

NCT06045429

Start Date

May 1 2024

End Date

December 1 2025

Last Update

July 26 2024

Active Locations (1)

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3rd Faculty of Medicine and FNKV

Prague, Czechia, 11000

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