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

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

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Other: Chlorhexidine; Other: Normal saline

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 Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine group; Applying 0.12% chlorhexidine mouthwash for oral care thrice daily.	Other: 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.
Active Comparator: Normal saline group; Applying normal saline for oral care thrice daily.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay	The total duration of the patient's ICU stay (days).	Will be surveyed retrospectively through study completion within 3 months
Hospital length of stay	The total duration of the patient's hospital stay (days).	Will be surveyed retrospectively through study completion within 3 months
ICU mortality	Whether the patient has died during their stay in the ICU	Will be surveyed retrospectively through study completion within 3 months
Hospital mortality	Whether the patient has died during their stay in the hospital	Will be surveyed retrospectively through study completion within 3 months
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.
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.
Incidence of Ventilator-Associated Pneumonia	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	From the date of intubation until the first occurrence of extubation or in-ICU death, whichever occurs first, assessed up to 28 days.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yi-Chen Lin, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: June 4, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Cross Infection; Iatrogenic Disease; Pneumonia; Pneumonia, Ventilator-Associated; Anti-Infective Agents; Anti-Infective Agents, Local; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 202106094RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No