Ventilator Associated PneumoniaNCT04505202
Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications
A study testing 0.12% chlorhexidine gluconate in people with Ventilator Associated Pneumonia and Tracheobronchitis, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilator Associated Pneumonia, Tracheobronchitis
- What is being tested?
- 0.12% chlorhexidine gluconate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2019to 3 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Admission in critical care with in 24 hours
- Having an endotracheal tube
Who cannot join
- 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
Show all 10Show fewer
- Patients with tracheostomies
- Required specific oral hygiene procedures
- Facio-maxillary or dental trauma/surgery
- Being pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabük University Training and Research Hospital
Karabük, Karabük Province, 78050
About this study
Official title: Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications in Patients With Mechanical Ventilation
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.
Read the 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.
- Conditions
- Ventilator Associated Pneumonia, Tracheobronchitis
- Being tested
- 0.12% chlorhexidine gluconate, Placebo
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.12% chlorhexidine gluconateDrug
The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care
PlaceboDrug
Also called sodium bicarbonate
The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 0.12% chlorhexidine gluconate Receives: Drug: 0.12% chlorhexidine gluconate |
| Placebo group | Placebo comparator | sodium bicarbonate Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathogen colonization change
We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)
Measured: 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
Measured: 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 )
Measured: 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)
Measured: change from baseline the rate of tracheobronchitis at Day 3
Secondary outcomes (2)
cost effectiveness
We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions.
Measured: Day 30
Mortality
rate of mortality
Measured: Day 7 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start15 Apr 2019
- Primary completion3 Mar 2020
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Kes, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505202
- Sponsor's protocol ID
- 2091
- Status last verified
- Oct 2020
- First submitted
- 30 Jul 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications in Patients With Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04505202
- Acronym / sponsor ID
- 2091
- Conditions
- Ventilator Associated Pneumonia, Tracheobronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: 0.12% chlorhexidine gluconate0.12% chlorhexidine gluconate |
| Placebo group | Placebo comparator | Drug: Placebosodium bicarbonate |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Admission in critical care with in 24 hours
- Having an endotracheal tube
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.12% chlorhexidine gluconateThe patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care | Drug | Experimental group |
| PlaceboAlso: sodium bicarbonateThe patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care | Drug | Placebo group |
Primary outcome
Pathogen colonization change
Time frame: change from baseline pathogen colonization at Day 3
We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)
Oral assessment guide score change
Time frame: 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
Clinical pulmonary infection score change
Time frame: 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 )
rate of tracheobronchitis change
Time frame: change from baseline the rate of tracheobronchitis at Day 3
Questionary (use the rate of tracheobronchitis categories)
2 secondary outcomes
cost effectiveness
Time frame: Day 30
Mortality
Time frame: Day 7 and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.12% chlorhexidine gluconate in people with Ventilator Associated Pneumonia and Tracheobronchitis, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathogen colonization change (time frame: change from baseline pathogen colonization at Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.