Reducing the Incidence of VAP in Critically Ill Children and Assessment of Oral Care With CHX
Primary Purpose
Ventilator Associated Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oral care with 0,12% Chlorhexidine
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring Oral care, Chlorhexidine, ventilator associated pneumonia
Eligibility Criteria
Inclusion Criteria:
- aged 1 month to 18 years
- needing MV for at least 48 hours
- PICU patients
Exclusion Criteria:
- not consenting to participate in the study
- known hypersensitivity to CHX
- presence of tracheotomy,
- undergoing MV for less than 48 hours
- having received MV for more than 24 hours prior to PICU admission
- readmission to PICU
- suspected or diagnosed immunodeficiency
- history of malignant disease(active or at remission),
- being diagnosed with oral mucositis or periodontal disease
- chronic pulmonary and/or cardiac diseases
- having severe oral/facial trauma,
- use of immunosuppressive drugs (such as corticosteroids).
Sites / Locations
- Istanbul Medeniyet University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Chlorhexidine
Placebo Group
Arm Description
5 ml of 0,12 % Chlorhexidine (CHX) solution is applied to the intervention group for oral care
Group of patients who received standard oral care
Outcomes
Primary Outcome Measures
Prevalance of VAP
Prevalance of VAP /1000 ventilator days (actual number of VAP episodes)
Characteristics of VAP
Early onset vs. late onset VAP rate
Secondary Outcome Measures
Causative organisms of VAP
Type of micro-organisms causing VAP in both groups
Duration of PICU stay
Median duration of PICU stay (days)
Duration of Hospital stay
Median duration of hospital stay (days)
Duration of ventilation
Median duration of mechanical ventilation (days)
Survival
Rate of survival
Causative organism of VAP
number of microorganism
Causative organism
percentage of microorganism causing VAP
Full Information
NCT ID
NCT04527276
First Posted
August 17, 2020
Last Updated
August 25, 2020
Sponsor
Istanbul Medeniyet University
1. Study Identification
Unique Protocol Identification Number
NCT04527276
Brief Title
Reducing the Incidence of VAP in Critically Ill Children and Assessment of Oral Care With CHX
Official Title
Reducing the Incidence of Ventilator Associated Pneumonia in Critically Ill Children: a Randomized Controlled Trial to Assess the Efficacy of Oral Mucosal Mouthwashes With Chlorhexidine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
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
This was a single-centered, randomized, placebo-controlled double-blind clinical trial conducted in the pediatric intensive care unit (PICU), in patients who were aged 1 month to 18 years, needing MV for at least 48 hours, to evaluate the effect of Chlorhexidine (CHX) on Ventilator-associated pneumonia (VAP) incidence and to determine VAP risk factors.
Detailed Description
Patients were randomized into two groups receiving CHX (0.12%) or placebo (0.9% NaCl) and followed for VAP development. All patients were consecutively randomized (1:1) to receive either 0.12% CHX rinse solution or placebo applications using a computer generated balanced randomization table. The unlabeled standardized tubes containing placebo or 0.12% CHX were serially numbered and bagged for each patient according to randomization. The preparation of bagged treatments and their numbering were done by the same personnel who was not involved in the study. The placebo rinse contained 0.9% NaCl (normal saline [NS]), and was identical to the 0.12% CHX rinse solution with regard to appearance, consistency, taste and smell. The patients, physicians, outcome assessors, and data analysts were kept blinded to the intervention.
The standard care protocols in the PICU were performed. Before beginning the study, nurses received a training program for VAP prevention, procedure/technique for oral hygiene and use of oral mucosa assessment score under supervision of pediatric residents. They were trained on the method of application of solutions according to CDC guidelines in order to ensure uniform treatments. Nurses were double blinded and had no knowledge of the solution they were using.
Both treatment groups (placebo and 0.12% CHX) received treatments at 4-hour intervals, nurses used the whole content of 5 ml tubes containing rinse solution. In both groups, nurses performed oral cleansing as follows: first, the endotracheal cuff pressure was tested to ensure proper pressure prior to oral care and oropharyngeal secretions were aspirated to remove any accumulated secretions. Then the application of rinse solutions to cleanse all areas of the oral cavity, including the anterior and posterior pharynx, gums, teeth, tongue, and buccal mucosa, with standard disposable applicator (foam swab) was applied, followed by removal of excess solution from the mouth by a sterile catheter. Strict hand hygiene was ensured during the procedures. The period of application was from the day of intubation until extubation. Presence of any adverse effect of the solutions was recorded. Beck oral assessment score (BOAS) was used twice daily to evaluate the oral health of both groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia
Keywords
Oral care, Chlorhexidine, ventilator associated pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All patients were consecutively randomized (1:1) to receive either 0.12% CHX rinse solution or placebo applications using a computer generated balanced randomization table.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine
Arm Type
Active Comparator
Arm Description
5 ml of 0,12 % Chlorhexidine (CHX) solution is applied to the intervention group for oral care
Arm Title
Placebo Group
Arm Type
No Intervention
Arm Description
Group of patients who received standard oral care
Intervention Type
Other
Intervention Name(s)
Oral care with 0,12% Chlorhexidine
Intervention Description
0, 12 % CHX, and standard oral care with 0,9% NaCl were compared to assess VAP rates. Both solutions were applied to critically ill children who were intubated.
Primary Outcome Measure Information:
Title
Prevalance of VAP
Description
Prevalance of VAP /1000 ventilator days (actual number of VAP episodes)
Time Frame
14 days
Title
Characteristics of VAP
Description
Early onset vs. late onset VAP rate
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Causative organisms of VAP
Description
Type of micro-organisms causing VAP in both groups
Time Frame
14 days
Title
Duration of PICU stay
Description
Median duration of PICU stay (days)
Time Frame
12 months
Title
Duration of Hospital stay
Description
Median duration of hospital stay (days)
Time Frame
12 months
Title
Duration of ventilation
Description
Median duration of mechanical ventilation (days)
Time Frame
12 months
Title
Survival
Description
Rate of survival
Time Frame
12 months
Title
Causative organism of VAP
Description
number of microorganism
Time Frame
14 days
Title
Causative organism
Description
percentage of microorganism causing VAP
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 1 month to 18 years
needing MV for at least 48 hours
PICU patients
Exclusion Criteria:
not consenting to participate in the study
known hypersensitivity to CHX
presence of tracheotomy,
undergoing MV for less than 48 hours
having received MV for more than 24 hours prior to PICU admission
readmission to PICU
suspected or diagnosed immunodeficiency
history of malignant disease(active or at remission),
being diagnosed with oral mucositis or periodontal disease
chronic pulmonary and/or cardiac diseases
having severe oral/facial trauma,
use of immunosuppressive drugs (such as corticosteroids).
Facility Information:
Facility Name
Istanbul Medeniyet University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34376358
Citation
Karakaya Z, Duyu M, Yersel MN. Oral mucosal mouthwash with chlorhexidine does not reduce the incidence of ventilator-associated pneumonia in critically ill children: A randomised controlled trial. Aust Crit Care. 2022 Jul;35(4):336-344. doi: 10.1016/j.aucc.2021.06.011. Epub 2021 Aug 8.
Results Reference
derived
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Reducing the Incidence of VAP in Critically Ill Children and Assessment of Oral Care With CHX
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