Using hydrogen peroxide for oral care in ICU patients to prevent pneumonia
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
This study is testing if using hydrogen peroxide for daily mouth care can help prevent pneumonia in patients on ventilators in the ICU.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT06045429 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of daily oral care using 3% hydrogen peroxide (Oroxid®) compared to standard care with 0.2% chlorhexidine in preventing lower respiratory tract microbial colonization in mechanically ventilated patients in the ICU. It is a single-center, randomized controlled trial that aims to determine if hydrogen peroxide can reduce the incidence of ventilator-associated pneumonia (VAP) and improve patient outcomes. The study will analyze various outcomes, including the risk of infection-related complications and length of ICU stay, over a period of three months.
Who should consider this trial
Good fit: Ideal candidates are adult ICU patients who are expected to be mechanically ventilated for at least 72 hours and have a Clinical Pulmonary Infection Score of less than 6.
Not a fit: Patients with active respiratory infections at admission, those requiring immediate antibiotic therapy, or those with a history of hydrogen peroxide allergy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of ventilator-associated pneumonia in critically ill patients, leading to better health outcomes and reduced healthcare costs.
How similar studies have performed: While the use of chlorhexidine has been standard, the application of hydrogen peroxide for this purpose is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years 2. In-patient of ICU and expected to stay \> 5 days 3. Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation (MV) ≥ 72h 4. Clinical Pulmonary Infection score (CPIS) less than 6 at the baseline 5. No history and symptoms of aspiration at the baseline Exclusion Criteria: 1. ATB therapy of respiratory infection on admission 2. Suspected pulmonary infection on admission and in the first 48h of mechanical ventilation 3. Pregnancy 4. Oral ulcers or injuries 5. Patient with a history of hydrogen peroxide allergy
Where this trial is running
Prague
- 3rd Faculty of Medicine and FNKV — Prague, Czechia (Recruiting)
Study contacts
- Principal investigator: Kateřina Jiroutková, MD — 3rd Faculty of Medicine, Charles University and FNKV, Prague
- Study coordinator: Kateřina Rambousková, MD
- Email: kacakoubkova@seznam.cz
- Phone: +420 721 185 134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.