Ventilator Associated PneumoniaNCT05913856
The Effectiveness of Oral Care With Chlorhexidine in Medical Intensive Care Unit
A study testing Normal saline and Chlorhexidine in people with Ventilator Associated Pneumonia, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Normal saline and Chlorhexidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Jan 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged over 20 years old
- admitted to MICU
- an oral endotracheal tube inserted under mechanically ventilated
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Normal saline, Chlorhexidine
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineOther
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.
ChlorhexidineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine group | Experimental | Applying 0.12% chlorhexidine mouthwash for oral care thrice daily. Receives: Other: Chlorhexidine |
| Normal saline group | Active comparator | Applying normal saline for oral care thrice daily. Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Will be surveyed retrospectively through study completion within 3 months
Secondary outcomes (7)
ICU length of stay
The total duration of the patient's ICU stay (days).
Measured: Will be surveyed retrospectively through study completion within 3 months
Hospital length of stay
The total duration of the patient's hospital stay (days).
Measured: Will be surveyed retrospectively through study completion within 3 months
ICU mortality
Whether the patient has died during their stay in the ICU
Measured: Will be surveyed retrospectively through study completion within 3 months
Hospital mortality
Whether the patient has died during their stay in the hospital
Measured: 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.
Measured: 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.
Measured: 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
Measured: From the date of intubation until the first occurrence of extubation or in-ICU death, whichever occurs first, assessed up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start4 Jan 2022
- Primary completion30 Jan 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Chen Lin, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913856
- Sponsor's protocol ID
- 202106094RINC
- Status last verified
- Aug 2024
- First submitted
- 4 Jun 2023
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Oral Care With Chlorhexidine in Medical Intensive Care Unit:Ventilator-associated Pneumonia and Patient Outcomes
- ClinicalTrials.gov ID
- NCT05913856
- Acronym / sponsor ID
- 202106094RINC
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine group | Experimental | Other: ChlorhexidineApplying 0.12% chlorhexidine mouthwash for oral care thrice daily. |
| Normal saline group | Active comparator | Other: Normal salineApplying normal saline for oral care thrice daily. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged over 20 years old
- admitted to MICU
- an oral endotracheal tube inserted under mechanically ventilated
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salineNormal 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. | Other | Normal saline group |
| Chlorhexidine15ml 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. | Other | Chlorhexidine group |
Primary outcome
Incidence of ventilator-associated event within ICU admission
Time frame: 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).
7 secondary outcomes
ICU length of stay
Time frame: Will be surveyed retrospectively through study completion within 3 months
Hospital length of stay
Time frame: Will be surveyed retrospectively through study completion within 3 months
ICU mortality
Time frame: Will be surveyed retrospectively through study completion within 3 months
Hospital mortality
Time frame: Will be surveyed retrospectively through study completion within 3 months
Changes in the oral health status evaluated by the Beck Oral Assessment Scale
Time frame: 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
Time frame: 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
Time frame: From the date of intubation until the first occurrence of extubation or in-ICU death, whichever occurs first, assessed up to 28 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
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Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Chen Lin principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline and Chlorhexidine in people with Ventilator Associated Pneumonia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ventilator-associated event within ICU admission (time frame: Will be surveyed retrospectively through study completion within 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.