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

Ventilator Associated Pneumonia Clinical Trial

Official title:

The Effectiveness of Oral Care With Chlorhexidine in Medical Intensive Care Unit:Ventilator-associated Pneumonia and Patient Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913856
• Other study ID #: 202106094RINC
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2022
• Source: National Taiwan University Hospital
• Contact: Yi-Chen Lin
• Phone: +886 932901357
• Email: r04426017[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 30, 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Other:
• Normal saline
Normal saline will be applied to irregate the oral cavity after the swabing of the surface of patients' teeth and oral cavity by a sponge swab by the primary care nurse in the MICU.
• Chlorhexidine
15ml of 0.12% chlorhexidine will be applied to irregate the oral cavity after the swabing of the surface of patients' teeth and oral cavity by a sponge swab by the primary care nurse in the MICU.

Locations

Country	Name	City	State
Taiwan	National taiwan university hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ventilator-associated event within ICU admission	The US CDC has proposed an objective diagnostic criteria to identify adverse events during mechanical ventilation, which comprises three levels: ventilator-associated condition (VAC), infection-related ventilator-associated condition (IVAC), and possible ventilator-associated pneumonia (PVAP).	Will be surveyed retrospectively through study completion within 3 months
Secondary	ICU length of stay	The total duration of the patient's ICU stay (days).	Will be surveyed retrospectively through study completion within 3 months
Secondary	Hospital length of stay	The total duration of the patient's hospital stay (days).	Will be surveyed retrospectively through study completion within 3 months
Secondary	ICU mortality	Whether the patient has died during their stay in the ICU	Will be surveyed retrospectively through study completion within 3 months
Secondary	Hospital mortality	Whether the patient has died during their stay in the hospital	Will be surveyed retrospectively through study completion within 3 months
Secondary	Changes in the oral health status evaluated by the Beck Oral Assessment Scale	The status of oral health will be evaluated using the Beck Oral Assessment Scale by the researcher, which provides a comprehensive evaluation of oral health by assessing various parameters such as lips, tongue, gums, and teeth.	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.
Secondary	Changes in the oral health status evaluated by the Mucosal-Plaque Score	The status of oral health will be evaluated using the Mucosal-Plaque Score by the researcher, which focuses specifically on assessing the presence and extent of mucosal inflammation and plaque accumulation in the oral cavity.	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.