Oral Hygiene, Oral HealthNCT05161962
Oral Care to Prevent Ventilator-associated Pneumonia
A study testing One group received standard oral care. and It was applied to the other group by aspiration. in people with Oral Hygiene, Oral Health and Ventilators, Mechanical, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Oral Hygiene, Oral Health, Ventilators, Mechanical
- What is being tested?
- One group received standard oral care. and It was applied to the other group by aspiration.
- 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
- 1 Sep 2019to 5 Feb 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:• Patients on mechanical ventilator who have been in intensive care for at least 48 hours
- Male and female patients over the age of 18
- Patients without thrombocytopenia, leukopenia and oral stomatitis, aphthae, candiasis, gingivitis
- Patients whose respiratory support is provided by a mechanical ventilator
- Patients who are considered to be able to provide mechanical ventilator support for 7 days
- Patients without any respiratory-related infectious pathogens
- Obtaining informed consent from the patient if he/she can give consent or from his/her guardian if he/she is unable to give consent.
- It was determined as patients who did not undergo any intraoral surgical intervention.
Exclusion Criteria: patients with pneumonia Patients younger than 18 years
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Oral Care Given by Two Different Methods in Patients Connected to Mechanical Ventilators on the Development of Ventilator-AssociatedPneumonia
This study was conducted to investigate the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.
Read the detailed description
The universe of this research, which was designed as a semi-experimental study, is composed of patients connected to the mechanical ventilator lying in Atatürk University Training and Research Hospital Anesthesia and Reanimation Intensive Care Unit between September 2019 and February 2020. A total of 57 patients, 29 method-1, 28 method-2 groups, met the inclusion criteria of the study. In the data collection phase, 'Patient Identifier Information Form', 'Patient Monitoring Form', 'Oral Assessment Scale' and 'Tracheal Aspirate Culture Result Form' were used. In the evaluation of the data, number and percentage distributions, Kruskal Wallis, Mann Withney-U, Wilcoxon Analysis, Chi-Square test were used.
- Conditions
- Oral Hygiene, Oral Health, Ventilators, Mechanical
- Being tested
- One group received standard oral care., It was applied to the other group by aspiration.
- Keywords
- Mechanical ventilation, nursing, oral care, pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One group received standard oral care.Combination product
the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.
It was applied to the other group by aspiration.Combination product
the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.
| Study group | Role | What they receive |
|---|---|---|
| One group received standard oral care. | Experimental | Not described Receives: Combination Product: One group received standard oral care.; Combination Product: It was applied to the other group by aspiration. |
| It was applied to the other group by aspiration. | Placebo comparator | Not described Receives: Combination Product: One group received standard oral care.; Combination Product: It was applied to the other group by aspiration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral care application with standard oral care stick
Administered with chlorhexidine gluconate solution.
Measured: 1 in 6 hours
Oral care application with a sucking oral care stick
Administered with chlorhexidine gluconate solution.
Measured: 1 in 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Sep 2019
- Primary completion23 Jan 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Hygiene, Oral HealthStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASENA KÖSE, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161962
- Sponsor's protocol ID
- AtaturkU-001
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 17 Dec 2021
- 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 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Oral Care Given by Two Different Methods in Patients Connected to Mechanical Ventilators on the Development of Ventilator-AssociatedPneumonia
- ClinicalTrials.gov ID
- NCT05161962
- Acronym / sponsor ID
- AtaturkU-001
- Conditions
- Oral Hygiene, Oral Health, Ventilators, Mechanical
- Keywords
- Mechanical ventilation, nursing, oral care, pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 17 Dec 2021 (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.
This study was conducted to investigate the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.
Detailed description
The universe of this research, which was designed as a semi-experimental study, is composed of patients connected to the mechanical ventilator lying in Atatürk University Training and Research Hospital Anesthesia and Reanimation Intensive Care Unit between September 2019 and February 2020. A total of 57 patients, 29 method-1, 28 method-2 groups, met the inclusion criteria of the study. In the data collection phase, 'Patient Identifier Information Form', 'Patient Monitoring Form', 'Oral Assessment Scale' and 'Tracheal Aspirate Culture Result Form' were used. In the evaluation of the data, number and percentage distributions, Kruskal Wallis, Mann Withney-U, Wilcoxon Analysis, Chi-Square test were used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One group received standard oral care. | Experimental | Combination Product: One group received standard oral care., Combination Product: It was applied to the other group by aspiration. |
| It was applied to the other group by aspiration. | Placebo comparator | Combination Product: One group received standard oral care., Combination Product: It was applied to the other group by aspiration. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| One group received standard oral care.the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators. | Combination product | It was applied to the other group by aspiration., One group received standard oral care. |
| It was applied to the other group by aspiration.the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators. | Combination product | It was applied to the other group by aspiration., One group received standard oral care. |
Primary outcome
oral care application with standard oral care stick
Time frame: 1 in 6 hours
Administered with chlorhexidine gluconate solution.
Oral care application with a sucking oral care stick
Time frame: 1 in 6 hours
Administered with chlorhexidine gluconate solution.
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 17 Dec 2021.
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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 One group received standard oral care. and It was applied to the other group by aspiration. in people with Oral Hygiene, Oral Health and Ventilators, Mechanical, run by Ataturk 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?
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 17 Dec 2021. 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?
oral care application with standard oral care stick (time frame: 1 in 6 hours). The study lists 2 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 17 Dec 2021.