Intensive Care PatientsNCT06733090
The Effect of Two Different Oral Care Solutions on the Prevention of Ventilator-associated Pneumonia in the Intensive Care Unit
A study testing 0.12% chlorhexidine glucanate solution and 0.2% chlorhexidine glucanate solution in people with Intensive Care Patients and Oral Care Performance, run by MELEK UNLUGEDIK at 1 site in Turkey (Türkiye).
Trial summary
Ventilator-associated pneumonia (VAP) is a lung parenchymal tissue infection that develops nosocomially 48-72 hours after the start of mechanical ventilation (8, 15, 17, 23, 31). The second most common nosocomial infection in intensive care units in the United States is VAP (20). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Patients, Oral Care Performance, Intensive Care Nurses
- What is being tested?
- 0.12% chlorhexidine glucanate solution and 0.2% chlorhexidine glucanate solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive mechanical ventilation support (at least 48 hours) 18 years of age or older Obtaining the approval of the legal guardian for his/her care
Who cannot join
- Chronically dependent on a ventilator Chlorhexidine gluconate sensitivity Diagnosed with VAP before the data collection process Semi-fawler position not applicable
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa
Istanbul, Avcilar, 34320
About this study
Ventilator-associated pneumonia (VAP) is a lung parenchymal tissue infection that develops nosocomially 48-72 hours after the start of mechanical ventilation (8, 15, 17, 23, 31). The second most common nosocomial infection in intensive care units in the United States is VAP (20). Approximately 90% of pneumonias developing in intensive care units are seen in patients receiving mechanical ventilation support, while the risk of VAP development is higher in the first days of hospitalization, and has been reported to be 3%/day in the first 5 days, 2%/day on the following six and ten days, and 1%/day on subsequent days (7, 20, 23,37). The concept of the Bundle of Care was first defined by the Institute for Healthcare Improvement in 2005 (21, 25). The Bundle of Care; It is a set of practices that have been beneficial in terms of clinical improvement, each of which includes 3-5 evidence-based, preventive interventions that contribute to the quality of care (5, 21, 25, 26, 30). There are studies in the literature showing that the use of the Care Bundle for the development of VAP reduces the rate of VAP development (5, 30, 34, 29, 28).
Evidence-based practices frequently recommended in the literature within the scope of the VAP Care Bundle are; giving the patient a semi-fowler position (sitting at a 30-45 degree angle), evaluating daily extubation, evaluating daily sedation, peptic ulcer prophylaxis unless contraindicated, and deep vein thrombosis prophylaxis (15, 21, 23, 26, 28, 30).
Read more
Health Care Improvement Institute; recommends washing hands before and after patient contact, removing subglottic secretions, and not changing ventilator circuits earlier than 48 hours (19, 21, 32, 33). In addition to evidence-based practices, the Institute for Health Care Improvement recommends that oral intubation be preferred to nasotracheal intubation, endotracheal tube cuff pressure should be between 20-30 cmH2O, enteral feeding should be initiated within 24-48 hours for hemodynamically stable intensive care patients, oral care should be performed with an antiseptic solution at 2-12 hour intervals, including teeth, cheeks, and tongue, monitoring humidifier filters and irrigation solutions, and aspiration should be performed under appropriate conditions. These interventions are considered evidence-based (1, 2, 3, 8, 9, 10, 11, 12, 14, 16, 18, 22, 23, 26, 33).
The evidence-based Care Bundle Interventions to be implemented by the researcher within the scope of this study are listed below. Interventions to be implemented by the nurse's decision include; Oral care with 0.12% chlorhexidine glucanate or 0.2% chlorhexidine glucanate solution, 4 times a day, at 6-hour intervals, semi-fowler position (sitting at a 30-45 degree angle) unless contraindicated, monitoring the endotracheal tube cuff pressure to be between 20-30 cmH2O, changing ventilator circuits and humidifier filters in case of visible contamination or malfunction, and monitoring the aspiration application. Interventions to be implemented by the physician's decision include; includes daily extubation assessment, peptic ulcer prophylaxis unless contraindicated, deep vein thrombosis prophylaxis unless contraindicated.
Read the detailed description
The study was planned to examine the effects of two different solutions (0.12% chlorhexidine glucanate and 0.2% chlorhexidine glucanate) on the incidence of VAP in patients who receive the VAP Care Bundle, which was created with evidence-based practices recommended in the literature, after the training to be given to nurses who provide care to patients on mechanical ventilation in the General Intensive Care Unit.
The study will be conducted in 2 stages. The first stage, in which nurses working in the Intensive Care Unit will be included in the sample group; was planned in a pretest-posttest design, in a single group, in order to determine the effectiveness of the training to be applied to the nurses.
The research will be conducted in two stages. The first stage, in which nurses working in the Intensive Care Unit will be included in the sample group, was planned in a pretest-posttest design, in a single group, in order to determine the effectiveness of the training to be given to nurses. The second stage was planned in a single-group, prospective experimental design, in order to determine the effect of the VİP Care Bundle application on the VİP incidence and the duration of stay on the ventilator. In the first stage of the research that nurses working in the General Intensive Care Unit of the Republic of Turkey Ministry of Health Silivri State Hospital will constitute the universe of the study. Those of these nurses who meet the inclusion criteria will be included in the sample group.
It will be conducted in the General Intensive Care Unit of the Republic of Turkey Ministry of Health Istanbul Silivri State Hospital. There are a total of 9 patient beds in the institution where the study will be implemented. The unit is a Level 3 intensive care unit. There are 20 nurses working in this unit. Nurse Information Form, Ventilator-Associated Pneumonia Information Test will be used.
In the second stage; after the completion of the nurse education program, patients who meet the inclusion criteria that will be grouped with simple randomization; Patient Information Form will be filled in on the day the patient is connected to the ventilator in the intensive care unit, VAP Prevention Protocol Monitoring Form and GKS (Glasgow Coma Scale) for each day the patient is connected to the ventilator, APACHE II (Acute Physiology and Chronic Health Evaluation II) 24 hours after the patient is admitted to the unit, and CPIS (Clinical Pulmonary Infection Score) will be filled in on the 1st, 3rd, and 5th hospitalization days following the patient's connection to the ventilator. At this stage, the oral health of the patients will be evaluated with the Oral Health Evaluation Form (permission was obtained from Assoc. Prof. Dr. Aylin Palloş via e-mail.). 0.12% chlorhexidine glucanate solution or 0.2% chlorhexidine glucanate solution will be used as oral care solution. The solutions are registered in the Product Tracking System of the Ministry of Health, Turkish Medicines and Medical Devices Agency. Oral care practices of the patients will be carried out in accordance with the Appendix 8. Special Oral Care Protocol, which was created by reviewing the literature (39,40). Oral care practices will be carried out by the researcher between 08:00-17:00 since the researcher is actively working in this intensive care unit. Oral care practices between 17:00-08:00 will be carried out by the nurse who has been trained and works in the night shift. The Information Form will be filled in by the researcher, the VAP Prevention Protocol Follow-up Form, the Oral Health Evaluation Form will be filled in by the nurses who provide care to the patient (The researcher is actively working in this intensive care unit), the GKS (Glasgow Coma Scale) will be filled in from the nurses' notes, the APACHE II (Acute Physiology and Chronic Health Evaluation II) will be filled in from the patient records (Institutional permission has been obtained), and the CPIS (Clinical Pulmonary Infection Score) will be filled in by the physician. The GKS (Glasgow Coma Scale) and APACHE II (Acute Physiology and Chronic Health Evaluation II) forms are routinely filled in the unit where the study is conducted for the patients in the sample group. The Oral Health Assessment Form will be filled in daily (24-hour intervals) after 4 applications for each patient, starting with the first assessment at admission, until the patient is discharged. The data obtained as a result of the study will be evaluated with appropriate statistical methods. In addition, the incidence of ventilator-associated pneumonia obtained at the end of the study will be compared with the data recorded by the Infection Control Committee for the General Intensive Care Unit and recorded in the Ministry of Health system. These dates correspond to 1 year before the period in which the research data were collected.
The second stage; 0.12% chlorhexidine glucanate solution or 0.2% chlorhexidine glucanate solution will be used in oral care with the standard VAP Care Bundle application. The group to which the patients will be included will be determined by the nurse in charge of the service through simple randomization. This study was planned in a two-group, prospective, experimental design to determine the effect of oral care intervention applied with two different solutions on the prevention of ventilator-associated pneumonia.
It was planned to examine the effect of two different solutions (0.12% chlorhexidine glucanate and 0.2% chlorhexidine glucanate) on the incidence of VAP in patients who used the VAP Care Bundle, which was created with evidence-based practices recommended in the literature, after the training to be given.
The research will be carried out in 2 stages. The first stage, in which nurses working in the Intensive Care Unit will be included in the sample group; It was planned in a pretest-posttest design, in a single group, in order to determine the effectiveness of the training to be applied to the nurses.
The second stage; 0.12% chlorhexidine glucanate solution or 0.2% chlorhexidine glucanate solution will be used in oral care with the standard VAP Care Bundle application. The group in which the patients will be included will be determined by the responsible nurse of the service through simple randomization. This study was planned as a two-group, prospective, experimental design to determine the effect of oral care intervention applied with two different solutions on the prevention of ventilator-associated pneumonia.
- Being tested
- 0.12% chlorhexidine glucanate solution, 0.2% chlorhexidine glucanate solution
- Keywords
- intensive care, oral care, oral care performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.12% chlorhexidine glucanate solutionDrug
The superiority of two different solutions over each other will be examined with a standard maintenance.
0.2% chlorhexidine glucanate solutionDrug
0.2% chlorhexidine glucanate solution
| Study group | Role | What they receive |
|---|---|---|
| 0.2% chlorhexidine glucanate solution | Experimental | 0.2% chlorhexidine glucanate solution Receives: Drug: 0.2% chlorhexidine glucanate solution |
| 0.12% chlorhexidine glucanate solution | Experimental | 0.12% chlorhexidine glucanate solution Receives: Drug: 0.12% chlorhexidine glucanate solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
APACHE II (Acute Physiology and Chronic Health Evalution II
Patients will be examined immediately after 24 hours after being admitted to intensive care. It will be looked at once.
Measured: It is filled only once for each patient, at the end of the 24th hour.
Follow-up period of patients checklist
It indicates how long patients will be followed. Patients are followed until they are discharged from intensive care and until they die. If ex or not discharged, the longest period is determined as 30 days.
Measured: If ex or not discharged, the longest period is determined as 30 days.
CPIS Clinical Pulmonary Infection Score
CPIS (Clinical Pulmonary Infection Score) will be filled in on the 1st, 3rd and 5th hospital days.
Measured: It is filled out once for the 1st, 3rd and 5th days when the patient is admitted to the intensive care unit.
GKS Glasgow Coma Scale
GKS Glasgow Coma Scale, It will be checked once a day every day. It is a method that aims to record a person's state of consciousness reliably and objectively at the beginning and in subsequent evaluations. When the patient is evaluated according to the criteria of the scale, the patient is given scores between 3 (indicating profound loss of consciousness) and 14 (according to the original scale) or 15 (according to the widely used corrected scale).
Measured: once a day on the day the patient is admitted to the intensive care unit, for a maximum of 30 days until death or discharge, whichever came first
Oral Health Evaluation Form
The oral health of the patients will be checked once a day by the researcher from the first moment throughout the study.
Measured: once a day on the day the patient is admitted to the intensive care unit, for a maximum of 30 days until death or discharge, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start23 Oct 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care PatientsStudies 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
- Single group
- Model description
- The study will be conducted in two stages. In the first stage; Nurse Information Form and Ventilator Associated Pneumonia Knowledge pretest will be applied to nurses who accept to participate in the study before the training. A 2-week training program will be applied to nurses by the researcher. In the second stage of the study, the forms in the second stage will be applied to patients who meet the criteria for inclusion in the study and the process will be followed in the same way in two separate groups. According to the research sample calculation, it is planned to include at least 25 patients in the experimental group and 25 patients in the control group.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MELEK UNLUGEDIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MELEK UNLUGEDIK, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733090
- Sponsor's protocol ID
- 0382
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I am the principal investigator and contact person.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Oral Care Solutions on the Prevention of Ventilator-associated Pneumonia in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06733090
- Acronym / sponsor ID
- 0382
- Keywords
- intensive care, oral care, oral care performance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MELEK UNLUGEDIKUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 13 Dec 2024 (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 (VAP) is a lung parenchymal tissue infection that develops nosocomially 48-72 hours after the start of mechanical ventilation (8, 15, 17, 23, 31). The second most common nosocomial infection in intensive care units in the United States is VAP (20). Approximately 90% of pneumonias developing in intensive care units are seen in patients receiving mechanical ventilation support, while the risk of VAP development is higher in the first days of hospitalization, and has been reported to be 3%/day in the first 5 days, 2%/day on the following six and ten days, and 1%/day on subsequent days (7, 20, 23,37). The concept of the Bundle of Care was first defined by the Institute for Healthcare Improvement in 2005 (21, 25). The Bundle of Care; It is a set of practices that have been beneficial in terms of clinical improvement, each of which includes 3-5 evidence-based, preventive interventions that contribute to the quality of care (5, 21, 25, 26, 30). There are studies in the literature showing that the use of the Care Bundle for the development of VAP reduces the rate of VAP development (5, 30, 34, 29, 28).
Evidence-based practices frequently recommended in the literature within the scope of the VAP Care Bundle are; giving the patient a semi-fowler position (sitting at a 30-45 degree angle), evaluating daily extubation, evaluating daily sedation, peptic ulcer prophylaxis unless contraindicated, and deep vein thrombosis prophylaxis (15, 21, 23, 26, 28, 30).
Health Care Improvement Institute; recommends washing hands before and after patient contact, removing subglottic secretions, and not changing ventilator circuits earlier than 48 hours (19, 21, 32, 33). In addition to evidence-based practices, the Institute for Health Care Improvement recommends that oral intubation be preferred to nasotracheal intubation, endotracheal tube cuff pressure should be between 20-30 cmH2O, enteral feeding should be initiated within 24-48 hours for hemodynamically stable intensive care patients, oral care should be performed with an antiseptic solution at 2-12 hour intervals, including teeth, cheeks, and tongue, monitoring humidifier filters and irrigation solutions, and aspiration should be performed under appropriate conditions. These interventions are considered evidence-based (1, 2, 3, 8, 9, 10, 11, 12, 14, 16, 18, 22, 23, 26, 33).
The evidence-based Care Bundle Interventions to be implemented by the researcher within the scope of this study are listed below. Interventions to be implemented by the nurse's decision include; Oral care with 0.12% chlorhexidine glucanate or 0.2% chlorhexidine glucanate solution, 4 times a day, at 6-hour intervals, semi-fowler position (sitting at a 30-45 degree angle) unless contraindicated, monitoring the endotracheal tube cuff pressure to be between 20-30 cmH2O, changing ventilator circuits and humidifier filters in case of visible contamination or malfunction, and monitoring the aspiration application. Interventions to be implemented by the physician's decision include; includes daily extubation assessment, peptic ulcer prophylaxis unless contraindicated, deep vein thrombosis prophylaxis unless contraindicated.
Detailed description
The study was planned to examine the effects of two different solutions (0.12% chlorhexidine glucanate and 0.2% chlorhexidine glucanate) on the incidence of VAP in patients who receive the VAP Care Bundle, which was created with evidence-based practices recommended in the literature, after the training to be given to nurses who provide care to patients on mechanical ventilation in the General Intensive Care Unit.
The study will be conducted in 2 stages. The first stage, in which nurses working in the Intensive Care Unit will be included in the sample group; was planned in a pretest-posttest design, in a single group, in order to determine the effectiveness of the training to be applied to the nurses.
The research will be conducted in two stages. The first stage, in which nurses working in the Intensive Care Unit will be included in the sample group, was planned in a pretest-posttest design, in a single group, in order to determine the effectiveness of the training to be given to nurses. The second stage was planned in a single-group, prospective experimental design, in order to determine the effect of the VİP Care Bundle application on the VİP incidence and the duration of stay on the ventilator. In the first stage of the research that nurses working in the General Intensive Care Unit of the Republic of Turkey Ministry of Health Silivri State Hospital will constitute the universe of the study. Those of these nurses who meet the inclusion criteria will be included in the sample group.
It will be conducted in the General Intensive Care Unit of the Republic of Turkey Ministry of Health Istanbul Silivri State Hospital. There are a total of 9 patient beds in the institution where the study will be implemented. The unit is a Level 3 intensive care unit. There are 20 nurses working in this unit. Nurse Information Form, Ventilator-Associated Pneumonia Information Test will be used.
In the second stage; after the completion of the nurse education program, patients who meet the inclusion criteria that will be grouped with simple randomization; Patient Information Form will be filled in on the day the patient is connected to the ventilator in the intensive care unit, VAP Prevention Protocol Monitoring Form and GKS (Glasgow Coma Scale) for each day the patient is connected to the ventilator, APACHE II (Acute Physiology and Chronic Health Evaluation II) 24 hours after the patient is admitted to the unit, and CPIS (Clinical Pulmonary Infection Score) will be filled in on the 1st, 3rd, and 5th hospitalization days following the patient's connection to the ventilator. At this stage, the oral health of the patients will be evaluated with the Oral Health Evaluation Form (permission was obtained from Assoc. Prof. Dr. Aylin Palloş via e-mail.). 0.12% chlorhexidine glucanate solution or 0.2% chlorhexidine glucanate solution will be used as oral care solution. The solutions are registered in the Product Tracking System of the Ministry of Health, Turkish Medicines and Medical Devices Agency. Oral care practices of the patients will be carried out in accordance with the Appendix 8. Special Oral Care Protocol, which was created by reviewing the literature (39,40). Oral care practices will be carried out by the researcher between 08:00-17:00 since the researcher is actively working in this intensive care unit. Oral care practices between 17:00-08:00 will be carried out by the nurse who has been trained and works in the night shift. The Information Form will be filled in by the researcher, the VAP Prevention Protocol Follow-up Form, the Oral Health Evaluation Form will be filled in by the nurses who provide care to the patient (The researcher is actively working in this intensive care unit), the GKS (Glasgow Coma Scale) will be filled in from the nurses' notes, the APACHE II (Acute Physiology and Chronic Health Evaluation II) will be filled in from the patient records (Institutional permission has been obtained), and the CPIS (Clinical Pulmonary Infection Score) will be filled in by the physician. The GKS (Glasgow Coma Scale) and APACHE II (Acute Physiology and Chronic Health Evaluation II) forms are routinely filled in the unit where the study is conducted for the patients in the sample group. The Oral Health Assessment Form will be filled in daily (24-hour intervals) after 4 applications for each patient, starting with the first assessment at admission, until the patient is discharged. The data obtained as a result of the study will be evaluated with appropriate statistical methods. In addition, the incidence of ventilator-associated pneumonia obtained at the end of the study will be compared with the data recorded by the Infection Control Committee for the General Intensive Care Unit and recorded in the Ministry of Health system. These dates correspond to 1 year before the period in which the research data were collected.
The second stage; 0.12% chlorhexidine glucanate solution or 0.2% chlorhexidine glucanate solution will be used in oral care with the standard VAP Care Bundle application. The group to which the patients will be included will be determined by the nurse in charge of the service through simple randomization. This study was planned in a two-group, prospective, experimental design to determine the effect of oral care intervention applied with two different solutions on the prevention of ventilator-associated pneumonia.
It was planned to examine the effect of two different solutions (0.12% chlorhexidine glucanate and 0.2% chlorhexidine glucanate) on the incidence of VAP in patients who used the VAP Care Bundle, which was created with evidence-based practices recommended in the literature, after the training to be given.
The research will be carried out in 2 stages. The first stage, in which nurses working in the Intensive Care Unit will be included in the sample group; It was planned in a pretest-posttest design, in a single group, in order to determine the effectiveness of the training to be applied to the nurses.
The second stage; 0.12% chlorhexidine glucanate solution or 0.2% chlorhexidine glucanate solution will be used in oral care with the standard VAP Care Bundle application. The group in which the patients will be included will be determined by the responsible nurse of the service through simple randomization. This study was planned as a two-group, prospective, experimental design to determine the effect of oral care intervention applied with two different solutions on the prevention of ventilator-associated pneumonia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be conducted in two stages. In the first stage; Nurse Information Form and Ventilator Associated Pneumonia Knowledge pretest will be applied to nurses who accept to participate in the study before the training. A 2-week training program will be applied to nurses by the researcher. In the second stage of the study, the forms in the second stage will be applied to patients who meet the criteria for inclusion in the study and the process will be followed in the same way in two separate groups. According to the research sample calculation, it is planned to include at least 25 patients in the experimental group and 25 patients in the control group.
| Arm | Type | Receives |
|---|---|---|
| 0.2% chlorhexidine glucanate solution | Experimental | Drug: 0.2% chlorhexidine glucanate solution0.2% chlorhexidine glucanate solution |
| 0.12% chlorhexidine glucanate solution | Experimental | Drug: 0.12% chlorhexidine glucanate solution0.12% chlorhexidine glucanate solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Invasive mechanical ventilation support (at least 48 hours) 18 years of age or older Obtaining the approval of the legal guardian for his/her care
Key exclusion criteria (1 listed)
- Chronically dependent on a ventilator Chlorhexidine gluconate sensitivity Diagnosed with VAP before the data collection process Semi-fawler position not applicable
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 glucanate solutionThe superiority of two different solutions over each other will be examined with a standard maintenance. | Drug | 0.12% chlorhexidine glucanate solution |
| 0.2% chlorhexidine glucanate solution0.2% chlorhexidine glucanate solution | Drug | 0.2% chlorhexidine glucanate solution |
Primary outcome
APACHE II (Acute Physiology and Chronic Health Evalution II
Time frame: It is filled only once for each patient, at the end of the 24th hour.
Patients will be examined immediately after 24 hours after being admitted to intensive care. It will be looked at once.
Follow-up period of patients checklist
Time frame: If ex or not discharged, the longest period is determined as 30 days.
It indicates how long patients will be followed. Patients are followed until they are discharged from intensive care and until they die. If ex or not discharged, the longest period is determined as 30 days.
CPIS Clinical Pulmonary Infection Score
Time frame: It is filled out once for the 1st, 3rd and 5th days when the patient is admitted to the intensive care unit.
CPIS (Clinical Pulmonary Infection Score) will be filled in on the 1st, 3rd and 5th hospital days.
GKS Glasgow Coma Scale
Time frame: once a day on the day the patient is admitted to the intensive care unit, for a maximum of 30 days until death or discharge, whichever came first
GKS Glasgow Coma Scale, It will be checked once a day every day. It is a method that aims to record a person's state of consciousness reliably and objectively at the beginning and in subsequent evaluations. When the patient is evaluated according to the criteria of the scale, the patient is given scores between 3 (indicating profound loss of consciousness) and 14 (according to the original scale) or 15 (according to the widely used corrected scale).
Oral Health Evaluation Form
Time frame: once a day on the day the patient is admitted to the intensive care unit, for a maximum of 30 days until death or discharge, whichever came first
The oral health of the patients will be checked once a day by the researcher from the first moment throughout the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No. I am the principal investigator and contact person.
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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 glucanate solution and 0.2% chlorhexidine glucanate solution in people with Intensive Care Patients and Oral Care Performance, run by MELEK UNLUGEDIK 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Dec 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
APACHE II (Acute Physiology and Chronic Health Evalution II (time frame: It is filled only once for each patient, at the end of the 24th hour.). The study lists 5 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 13 Dec 2024.