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

NCT ID: NCT04505202

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2020-09-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ventilator Associated Pneumonia Tracheobronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group

0.12% chlorhexidine gluconate

Group Type EXPERIMENTAL

0.12% chlorhexidine gluconate

Intervention Type DRUG

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

Placebo group

sodium bicarbonate

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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0.12% chlorhexidine gluconate

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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sodium bicarbonate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karabuk University

OTHER

Sponsor Role lead

Responsible Party

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Duygu Kes

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karabük University Training and Research Hospital

Karabük, Karabük Province, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2091

Identifier Type: -

Identifier Source: org_study_id