The Effectiveness of Oral Care With Chlorhexidine in Medical Intensive Care Unit

National Taiwan University

Status: Completed

Conditions: Ventilator Associated Pneumonia

Treatments: Other: Chlorhexidine; Other: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05913856

202106094RINC

Details and patient eligibility

About

Oral care with chlorhexidine was used to be considered an effective way to prevent ventilator-associated pneumonia (VAP). However, recent evidence revealed that oral care with chlorhexidine may associate with higher mortality and increasing risks of acute respiratory distress syndrome due to the aspiration of chlorhexidine. In addition, the majority of relevant studies in the past have only focused on cardiothoracic intensive care unit (ICU) or post-operation patients. Thus, whether this is effective and safe for medical ICU patients remains unclear.

Full description

Ventilator-associated pneumonia (VAP) is one of the most common hospital-acquired infections in the ICU, associated with an increased hospital stay, increased cost of treatment, prolonged ventilator days, and increased morbidity and mortality rates (Divatia et al, 2019). The overall incidence of VAP was around 12% in Asia and nearly 8% in Taiwan in the past 30 years (Bonell et al, 2019), with a mortality rate that may exceed 45% for those receiving mechanical ventilation (Feng et al, 2019). Therefore, the prevention of VAP is a key part of managing patients undergoing mechanical ventilation.

Oral decolonization by mouthwash using a chlorhexidine-contained solution was suggested by accumulated evidence in preventing VAP (Dai et al, 2022). However, controversial opinions existed from a few different points of view. First of all, Klompas et al (2014) conducted a meta-analysis that showed the effectiveness of chlorhexidine (CHG) oral care in preventing VAP was limited only to cardiac surgery patients (Klomopas et al, 2014). Second, recent evidence showed a possibility of unfavored outcomes related to the use of CHG mouthwash by increased mortality either in the ICU (Price et al, 2014) or the general ward (Deschepper et al, 2018). Last but not least, the subjectiveness of the diagnostic criteria of VAP had led to the discussion on the credibility of the outcome in relevant studies (Skrupky et al, 2016). Therefore, the US Centers for Disease Control and the National Healthcare Safety Network have proposed alternative diagnostic criteria for the ventilator-associated event (VAE) as alternation (Peña-López et al, 2022).

The objective of this study was to examine the effectiveness of oral care with 0.12% CHG in MICU patients for the prevention of ventilator-associated events.

Enrollment: 141 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged over 20 years old
• admitted to MICU
• an oral endotracheal tube inserted under mechanically ventilated

Exclusion criteria

• an endotracheal tube inserted over 24 hours before enrollment
• intubated because of trauma, burn, operation, or neurological disease
• already suffered from oral ulcers before intubation
• known history of allergic reaction to CHG
• use of ECMO

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

141 participants in 2 patient groups

Chlorhexidine group

Experimental group

Description:

Applying 0.12% chlorhexidine mouthwash for oral care thrice daily.

Treatment:

Other: Chlorhexidine

Normal saline group

Active Comparator group

Description:

Applying normal saline for oral care thrice daily.

Treatment:

Other: Normal saline