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Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications

Sponsor
Karabuk University (Other)
Overall Status
Completed
CT.gov ID
NCT04505202
Collaborator
(none)
57
Enrollment
1
Location
2
Arms
16.7
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ventilator-associated pneumonia and ventilator-associated treakeabronchitis in respiratory tract infections associated with ventilator are common infections in intensive care unit and cause significant morbidity, mortality and health expenditures in nosocomial infections. Adequate and effective oral care by nurses in intensive care patients, possible complications, intensive care unit stay in the intensive care unit and is very important in terms of mortality.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.12% chlorhexidine gluconate
  • Drug: Placebo
 N/A

Detailed Description

The aim of this study will (1) evaluate the effect of 0.12% chlorhexidine gluconate on ventilator-associated pneumonia, ventilator-associated treakeabronchitis, (2) determine the effect of preventing microorganism colonization, and (3) assess the mortality rate for each patient and the cost-effectiveness in the health expenditures.

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications in Patients With Mechanical Ventilation
Actual Study Start Date :
Apr 15, 2019
Actual Primary Completion Date :
Mar 3, 2020
Actual Study Completion Date :
Sep 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

0.12% chlorhexidine gluconate

Drug: 0.12% chlorhexidine gluconate
The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care
Placebo Comparator: Placebo group

sodium bicarbonate

Drug: Placebo
The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care
Other Names:
  • sodium bicarbonate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pathogen colonization change [change from baseline pathogen colonization at Day 3]

      We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)

    2. Oral assessment guide score change [at the time of admission into the study (day 0), at study day 2 and at day 3]

      The score ranges from 8 to 24 and higher scores indicating worse oral health

    3. Clinical pulmonary infection score change [at the time of admission into the study (day 0), at study day 2 and at day 3]

      The score ranges from 0 to 12 (ventilator-associated pneumonia ≥ 6 )

    4. rate of tracheobronchitis change [change from baseline the rate of tracheobronchitis at Day 3]

      Questionary (use the rate of tracheobronchitis categories)

    Secondary Outcome Measures

    1. cost effectiveness [Day 30]

      We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions.

    2. Mortality [Day 7 and Day 28]

      rate of mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age ≥ 18 years

    • Admission in critical care with in 24 hours

    • Having an endotracheal tube

    Exclusion Criteria:

    • History of chlorhexidine allergy

    • Duration of mechanichal ventilation less than 48 h

    • Confirmed diagnosis of pneumonitis before admission in the ICU

    • Transfer from another ICU

    • Receiving chemotherapy or radiotherapy

    • Patients with immunodeficiency

    • Patients with tracheostomies

    • Required specific oral hygiene procedures

    • Facio-maxillary or dental trauma/surgery

    • Being pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karabük University Training and Research Hospital Karabük Karabuk Turkey 78050

    Sponsors and Collaborators

    • Karabuk University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duygu Kes, Principal Investigator, Karabuk University
    ClinicalTrials.gov Identifier:
    NCT04505202
    Other Study ID Numbers:
    • 2091
    First Posted:
    Aug 10, 2020
    Last Update Posted:
    Oct 30, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pneumonia, Ventilator-Associated
    Chlorhexidine
    Chlorhexidine gluconate

    Study Results

    No Results Posted as of Oct 30, 2020