Reducing the Incidence of VAP in Critically Ill Children and Assessment of Oral Care With CHX

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

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Other: Oral care with 0,12% Chlorhexidine

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.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Medeniyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chlorhexidine; 5 ml of 0,12 % Chlorhexidine (CHX) solution is applied to the intervention group for oral care	Other: Oral care with 0,12% Chlorhexidine; 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.
No Intervention: Placebo Group; Group of patients who received standard oral care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalance of VAP	Prevalance of VAP /1000 ventilator days (actual number of VAP episodes)	14 days
Characteristics of VAP	Early onset vs. late onset VAP rate	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Causative organisms of VAP	Type of micro-organisms causing VAP in both groups	14 days
Duration of PICU stay	Median duration of PICU stay (days)	12 months
Duration of Hospital stay	Median duration of hospital stay (days)	12 months
Duration of ventilation	Median duration of mechanical ventilation (days)	12 months
Survival	Rate of survival	12 months
Causative organism of VAP	number of microorganism	14 days
Causative organism	percentage of microorganism causing VAP	14 days

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: ventilator associated pneumonia; Chlorhexidine; Oral care
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: IstanbulIMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No