Effects of Oral Care With 3% Hydrogen Peroxide (Oroxid4) on Lower Respiratory Tract Microbial Colonisation in Mechanically Ventilated Adult Critically Ill Patients: A Single-Centre Randomised Controlled Trial

What this Trial Is About

Researchers are evaluating the effects of daily oral care using 3% hydrogen peroxide (Oroxid4) compared to standard care with 0.2% chlorhexidine digluconate in adult critically ill patients who are mechanically ventilated in the intensive care unit (ICU). This study aims to determine whether the hydrogen peroxide solution can reduce the incidence of lower respiratory tract microbial colonization, which is linked to ventilator-associated pneumonia (VAP), a common and serious hospital-acquired infection with significant impacts on patient health and hospital resources. Participants are randomly assigned to one of two groups. The intervention group receives daily oral care with 3% hydrogen peroxide mouthwash, including oral assessment and teeth brushing twice daily. The control group receives protocolized daily oral care with 0.2% chlorhexidine following the same oral care schedule. Both groups receive standard medical and nursing care to prevent VAP, including routine microbial surveillance of tracheal aspirates twice a week and as needed based on clinical status. During the study, researchers monitor microbial colonization in the lower respiratory tract, using statistical methods to track incidence over time, with censoring for ICU discharge or extubation beyond 24 hours. Additional outcomes include the risk of ventilator-associated complications, antibiotic use, oral health assessed by a bedside oral exam score, length of ICU stay, and days free from ventilator support within 28 days. The study duration includes follow-up periods of up to three months for some outcomes, with close monitoring of participant oral and respiratory health throughout.

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