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

Not Applicable

Completed

• Conditions: Ventilator Associated Pneumonia
• Interventions: Other: Chlorhexidine; Other: Normal saline

• Registration Number: NCT05913856
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2022-01-04
• Primary Completion: 2022-01-30
• Study First Submitted: 2023-06-04
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-22
• Study Completion: 2023-12-30
• Status Verified: 2024-08
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine group	Chlorhexidine	Applying 0.12% chlorhexidine mouthwash for oral care thrice daily.
Normal saline group	Normal saline	Applying normal saline for oral care thrice daily.

Primary Outcome Measures

Name	Time	Method
Incidence of ventilator-associated event within ICU admission	Will be surveyed retrospectively through study completion within 3 months	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).

Secondary Outcome Measures

Name	Time	Method
Hospital mortality	Will be surveyed retrospectively through study completion within 3 months	Whether the patient has died during their stay in the hospital
ICU length of stay	Will be surveyed retrospectively through study completion within 3 months	The total duration of the patient's ICU stay (days).
Hospital length of stay	Will be surveyed retrospectively through study completion within 3 months	The total duration of the patient's hospital stay (days).
ICU mortality	Will be surveyed retrospectively through study completion within 3 months	Whether the patient has died during their stay in the ICU
Changes in the oral health status evaluated by the Beck Oral Assessment Scale	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.	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.
Changes in the oral health status evaluated by the Mucosal-Plaque Score	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.	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.
Incidence of Ventilator-Associated Pneumonia	From the date of intubation until the first occurrence of extubation or in-ICU death, whichever occurs first, assessed up to 28 days.	Ventilator-associated pneumonia (VAP) will be included as an additional secondary outcome. Diagnosis of VAP will follow the 2016 Infectious Diseases Society of America (IDSA) and American Thoracic Society (ATS) clinical practice guidelines.; A case of VAP is defined by the presence of a new or progressive pulmonary infiltrate on chest radiograph, plus at least two of the following clinical features: Fever \>38°C or hypothermia \<36°C,leukocytosis (\>12,000/μL) or leukopenia (\<4,000/μL), or purulent tracheal secretions.; Chart reviews will be conducted in a two-step process: (1) initial screening by trained research staff based on clinical documentation (excluding radiographic findings), and (2) blinded interpretation of chest X-rays by a physician reviewer. The diagnostic window for VAP will be based on the temporal cluster of clinical signs, typically within ±48 hours. The outcome will be reported as the number of VAP cases per group, and if data permits, as incidence per 1,000 ventilator

Trial Locations

Locations (1)

National taiwan university hospital; 🇨🇳 Taipei, Taiwan