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

NCT ID: NCT05913856

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2023-12-30

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.

Conditions

Ventilator Associated Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Chlorhexidine group

Applying 0.12% chlorhexidine mouthwash for oral care thrice daily.

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: OTHER

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.

Normal saline group

Applying normal saline for oral care thrice daily.

Group Type: ACTIVE_COMPARATOR

Normal saline

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Chen Lin

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National taiwan university hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202106094RINC

Identifier Type: -

Identifier Source: org_study_id