NCT04505202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2020

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

July 30, 2020

Last Update Submit

October 29, 2020

Conditions

Ventilator Associated PneumoniaTracheobronchitis

Outcome Measures

Primary Outcomes (4)

  • Pathogen colonization change

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

    change from baseline pathogen colonization at Day 3

  • Oral assessment guide score change

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

    at the time of admission into the study (day 0), at study day 2 and at day 3

  • Clinical pulmonary infection score change

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

    at the time of admission into the study (day 0), at study day 2 and at day 3

  • rate of tracheobronchitis change

    Questionary (use the rate of tracheobronchitis categories)

    change from baseline the rate of tracheobronchitis at Day 3

Secondary Outcomes (2)

  • cost effectiveness

    Day 30

  • Mortality

    Day 7 and Day 28

Study Arms (2)

Experimental group

EXPERIMENTAL

0.12% chlorhexidine gluconate

Drug: 0.12% chlorhexidine gluconate

Placebo group

PLACEBO COMPARATOR

sodium bicarbonate

Drug: Placebo

Interventions

0.12% chlorhexidine gluconateDRUG

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

Experimental group
PlaceboDRUG

The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care

Also known as: sodium bicarbonate
Placebo group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Admission in critical care with in 24 hours
  • Having an endotracheal tube

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabük University Training and Research Hospital

Karabük, Karabük Province, 78050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

chlorhexidine gluconateSodium Bicarbonate

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 10, 2020

Study Start

April 15, 2019

Primary Completion

March 3, 2020

Study Completion

September 3, 2020

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations

TU(1)