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

Primary Purpose

Ventilator Associated Pneumonia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Normal saline
Chlorhexidine
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator Associated Pneumonia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National taiwan university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chlorhexidine group

Normal saline group

Arm Description

Applying 0.12% chlorhexidine mouthwash for oral care thrice daily.

Applying normal saline for oral care thrice daily.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

ICU length of stay
The total duration of the patient's ICU stay (days).
Hospital length of stay
The total duration of the patient's hospital stay (days).
ICU mortality
Whether the patient has died during their stay in the ICU
Hospital mortality
Whether the patient has died during their stay in the hospital
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.
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.

Full Information

First Posted
June 4, 2023
Last Updated
June 13, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05913856
Brief Title
The Effectiveness of Oral Care With Chlorhexidine in Medical Intensive Care Unit
Official Title
The Effectiveness of Oral Care With Chlorhexidine in Medical Intensive Care Unit:Ventilator-associated Pneumonia and Patient Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine group
Arm Type
Experimental
Arm Description
Applying 0.12% chlorhexidine mouthwash for oral care thrice daily.
Arm Title
Normal saline group
Arm Type
Active Comparator
Arm Description
Applying normal saline for oral care thrice daily.
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
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
Intervention Name(s)
Chlorhexidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of ventilator-associated event within ICU admission
Description
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).
Time Frame
Will be surveyed retrospectively through study completion within 3 months
Secondary Outcome Measure Information:
Title
ICU length of stay
Description
The total duration of the patient's ICU stay (days).
Time Frame
Will be surveyed retrospectively through study completion within 3 months
Title
Hospital length of stay
Description
The total duration of the patient's hospital stay (days).
Time Frame
Will be surveyed retrospectively through study completion within 3 months
Title
ICU mortality
Description
Whether the patient has died during their stay in the ICU
Time Frame
Will be surveyed retrospectively through study completion within 3 months
Title
Hospital mortality
Description
Whether the patient has died during their stay in the hospital
Time Frame
Will be surveyed retrospectively through study completion within 3 months
Title
Changes in the oral health status evaluated by the Beck Oral Assessment Scale
Description
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.
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.
Title
Changes in the oral health status evaluated by the Mucosal-Plaque Score
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Chen Lin
Phone
+886 932901357
Email
r04426017@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Chen Lin
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National taiwan university hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Chen Lin
Phone
886932901357
Email
r04426017@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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

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