Clinical trial NCT05913856: The Effectiveness of Oral Care With Chlorhexidine in Medical Intensive Care Unit
Official title: The Effectiveness of Oral Care With Chlorhexidine in Medical Intensive Care Unit:Ventilator-associated Pneumonia and Patient Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Associated Pneumonia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 141
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of ventilator-associated event within ICU admission
timeFrame: Will be surveyed retrospectively through study completion within 3 months
Secondary outcomes:
measure: ICU length of stay
timeFrame: Will be surveyed retrospectively through study completion within 3 months
measure: Hospital length of stay
timeFrame: Will be surveyed retrospectively through study completion within 3 months
measure: ICU mortality
timeFrame: Will be surveyed retrospectively through study completion within 3 months
measure: Hospital mortality
timeFrame: Will be surveyed retrospectively through study completion within 3 months
measure: Changes in the oral health status evaluated by the Beck Oral Assessment Scale
timeFrame: The surveys will be conducted within 24 hours of patient enrollment, within the fourth day after the patient is intubated, and within the 1 day following extubation.
measure: Changes in the oral health status evaluated by the Mucosal-Plaque Score
timeFrame: The surveys will be conducted within 24 hours of patient enrollment, within the fourth day after the patient is intubated, and within the 1 day following extubation.
measure: Incidence of Ventilator-Associated Pneumonia
timeFrame: From the date of intubation until the first occurrence of extubation or in-ICU death, whichever occurs first, assessed up to 28 days.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National taiwan university hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Chen Lin
role: PRINCIPAL_INVESTIGATOR
References: