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

NCT05913856 | Completed

• 1 other identifier: 202106094RINC
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• ICU length of stay

  Will be surveyed retrospectively through study completion within 3 months

• Hospital length of stay

  Will be surveyed retrospectively through study completion within 3 months

• ICU mortality

  Will be surveyed retrospectively through study completion within 3 months

• Hospital mortality

  Will be surveyed retrospectively through study completion within 3 months

• 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.

Study Arms (2)

Chlorhexidine group

EXPERIMENTAL

Applying 0.12% chlorhexidine mouthwash for oral care thrice daily.

Other: Chlorhexidine

Normal saline group

ACTIVE COMPARATOR

Applying normal saline for oral care thrice daily.

Other: Normal saline

Interventions

Normal saline 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.

Normal saline group

Chlorhexidine 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.

Chlorhexidine group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged over 20 years old
• admitted to MICU
• an oral endotracheal tube inserted under mechanically ventilated

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National taiwan university hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Saline Solution; Chlorhexidine

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Yi-Chen Lin

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 22, 2023
• Study Start: January 4, 2022
• Primary Completion: January 30, 2022
• Study Completion: December 30, 2023
• Last Updated: May 8, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)