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

NCT04527276 | Completed

• 1 other identifier: IstanbulIMU
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia

Keywords

Oral care; Chlorhexidine; ventilator associated pneumonia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Causative organisms of VAP

  14 days

• Duration of PICU stay

  12 months

• Duration of Hospital stay

  12 months

• Duration of ventilation

  12 months

• Survival

  12 months

Study Arms (2)

Chlorhexidine

ACTIVE COMPARATOR

5 ml of 0,12 % Chlorhexidine (CHX) solution is applied to the intervention group for oral care

Other: Oral care with 0,12% Chlorhexidine

Placebo Group

NO INTERVENTION

Group of patients who received standard oral care

Interventions

Oral care with 0,12% Chlorhexidine OTHER

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.

Chlorhexidine

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged 1 month to 18 years
• needing MV for at least 48 hours
• PICU patients

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34376358 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 26, 2020
• Study Start: February 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 31, 2020
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)