PneumoniaNCT06258603
Oral Care of Intubated Intensive Care Patient
A study testing oral care bundle and clinical oral care in people with Pneumonia and Mechanical Ventilation Complication, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the research was to examine the effect of oral care bundle application on oral health, salivary pH (power of hydrogen), dry mouth and ventilator associated pneumonia in intubated patients compared to standard oral care. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Mechanical Ventilation Complication, Salivation
- What is being tested?
- oral care bundle and clinical oral care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 19 Jun 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mechanical ventilation support,
- orally intubation
- in the first 24 hours of intubation,
- stable hemodynamic status
Who cannot join
- pneumonia
- Sjögren's Syndrome,
- radiotherapy and/or chemotherapy,
- oral care contraindications,
- head and neck trauma,
- platelet count below 50 thousand,
- could not be positioned appropriately,
- agitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Care Bundle Application on Salivary pH (Power of Hydrogen), Dry Mouth and Ventilator-associated Pneumonia in Intubated Patients
The aim of the research was to examine the effect of oral care bundle application on oral health, salivary pH (power of hydrogen), dry mouth and ventilator associated pneumonia in intubated patients compared to standard oral care.
Read the detailed description
Maintaining the integrity of the oral mucosa in intensive care unit patients is very important due to its close relationship with systemic health, disease risk and self-image, as well as comfort and nutrition. Serious problems develop in patients who have no or insufficient saliva movement or production, are unconscious, or have an artificial airway. Oral health problems, which begin with the deterioration of the saliva flow and content of intubated patients, lead to much more risky and costly situations that end in ventilator associated pneumonia. In the literature, it is seen that oral care practices performed in accordance with protocols increase the risk of complications and that bundle care practices used in different care areas increase the performance of care.In this randomized controlled study, people who were aged between 18 and 70, had received mechanical ventilation support, were intubated orally and in the first 24 hours of intubation, and had a stable hemodynamic status were included in the study.
- Conditions
- Pneumonia, Mechanical Ventilation Complication, Salivation, Dry Mouth
- Being tested
- oral care bundle, clinical oral care
- Keywords
- oral health, oral care, intensive care, nursing, intubation, dry mouth
- Medical subject headings
- Pneumonia, Sialorrhea, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral care bundleOther
In the first stage, oral health was evaluated and data about the patient was collected.
In the second stage, an oral care bundle containing an oral care combination was applied to the experimental group. According to this bundle application, patients were received tooth brushing (with chlorhexidine solution) and ice water application twice a day and moisturizing attempts 4 times a day.
In the 3rd stage, saliva pH, dry mouth (amount of salivation) and ventilator associated pneumonia development status of the experimental group patients were evaluated.
Measurements were made by the researcher using the Bedside Oral Exam scale, pH (power of hydrogen) strip and Schirmer Tear Test Strip.
Data regarding whether patients were diagnosed with ventilator associated pneumonia were obtained from the Infection Control Committee.
clinical oral careOther
In the first stage, oral health was evaluated and data about the patient was collected.
In the second stage, routine oral care protocol used in intensive care unit was applied to patients by the patients' primary nurse. According to this application, patients were received oral care using tongue depressor with wrapped in gauze and chlorhexidine solution 4 times a day.
In the 3rd stage, saliva pH (power of hydrogen), dry mouth (amount of salivation) and ventilator associated pneumonia development status of the experimental group patients were evaluated.
Measurements were made by the researcher using the Bedside Oral Exam scale, pH (power of hydrogen) strip and Schirmer Tear Test Strip.
Data regarding whether patients were diagnosed with ventilator associated pneumonia were obtained from the Infection Control Committee.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received oral care bundle | Experimental | "A oral care bundle" protocol created by the researchers and it was applied by a researcher to experimental group. Receives: Other: oral care bundle |
| Patients receiving routine clinical oral care | Other | Routine oral care protocol used in intensive care unit was applied to control group by the patient's primary nurse. Receives: Other: clinical oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual Identification Form
The form was prepared by the researcher in line with literature information. It consists of 9 questions covering the characteristics of the patients (demographic characteristics, diagnoses, APACHE II scores, Glasgow Coma Scale score, rules, feeding patterns, intubation tube number).
Measured: First day of data collection
Bedside Oral Exam Scale
Oral health was assessed using the scale. The scale consists of 8 subheadings (swallowing, lips, tongue, saliva, mucous membranes, gums, teeth or dentures, and smell). The scale score ranges from 8 points (perfect oral health) to 24 points (impaired oral health).
Measured: Evaluated for five days.
In this outcome measure, the patients'vsaliva pH (power of hydrogen) was evaluated.
Merck brand Universal pH 0-14 indicator was used to measure the saliva pH of the patients. The indicator was placed on the tongue and waited for 1 minute, and the resulting color change was compared with the color scale on the box. According to the literature, the average pH of unstimulated saliva has been determined to be approximately 6.8.
Measured: The 1st, 3rd and 5th days of oral care practices
In this outcome measure, the patients' saliva amount was evaluated.
Schirmer Tear Test Strip was used in the application. The Modified Schirmer Test strip was placed under the tongue by holding its end with forceps, and after waiting for 3 minutes, the mm value of the wetness on the strip was read.
Measured: The 1st, 3rd and 5th days of oral care practices.
In this outcome measure, it was evaluated whether ventilator-associated pneumonia occured in patients receiving care.
To avoid bias regarding the method used, the diagnosis of ventilator associated pneumonia was made independently by the treatment team. In the Intensive Care Unit of Ege University Faculty of Medicine, Department of Anesthesiology and Reanimation, the diagnosis of ventilator associated pneumonia is made by the physician using the nosocomial infection diagnostic criteria of The Centers for Disease Control and Prevention (CDC). Information about the development of ventilator associated pneumonia was obtained from the infection control nurse.
Measured: Evaluated for five days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 May 2019
- Primary completion30 Dec 2021
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- The randomization of the study was achieved by the faculty member of the University's Faculty of Medicine, Department of Biostatistics and Medical Informatics, with the R version 3.1.3 program. First of all, the individuals included in the study were stratified according to two age groups (19-44 years and 45-70 years) in the computer environment. Then, individuals in each age group were included in the experimental and control groups in a balanced manner using the block randomization method. The randomization list was hidden from the researcher and the patient and was given to the researcher by a third party during the application. Eligibility and randomization assessment was performed by a critical care nurse independent of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Gül Güneş AKTAN, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258603
- Sponsor's protocol ID
- 19-5T/40
- Status last verified
- Feb 2024
- First submitted
- 19 Dec 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published
Publications
Abdelhafez AI, Tolba AA. Nurses' practices and obstacles to oral care quality in intensive care units in Upper Egypt. Nurs Crit Care. 2023 May;28(3):411-418. doi: 10.1111/nicc.12736. Epub 2021 Dec 2.
PubMed 34855285Alja'afreh MA, Mosleh SM, Habashneh SS. The Effects of Oral Care Protocol on the Incidence of Ventilation-Associated Pneumonia in Selected Intensive Care Units in Jordan. Dimens Crit Care Nurs. 2019 Jan/Feb;38(1):5-12. doi: 10.1097/DCC.0000000000000334.
PubMed 30499786Andersson P, Persson L, Hallberg IR, Renvert S. Testing an oral assessment guide during chemotherapy treatment in a Swedish care setting: a pilot study. J Clin Nurs. 1999 Mar;8(2):150-8. doi: 10.1046/j.1365-2702.1999.00237.x.
PubMed 10401348Blot S, Deschepper M, Labeau S. De-adoption of chlorhexidine oral care and ICU mortality. Intensive Care Med. 2022 May;48(5):624-625. doi: 10.1007/s00134-022-06621-4. Epub 2022 Jan 17. No abstract available.
PubMed 35037992Chair SY, Chan DWK, Cao X. The interaction of subglottic drainage, cuff pressure, and oral care on endotracheal tube fluid leakage: A benchtop study. Aust Crit Care. 2020 Jul;33(4):358-363. doi: 10.1016/j.aucc.2019.05.002. Epub 2019 Jun 24.
PubMed 31248697Cuthbertson BH, Dale CM. Less daily oral hygiene is more in the ICU: yes. Intensive Care Med. 2021 Mar;47(3):328-330. doi: 10.1007/s00134-020-06261-6. Epub 2020 Oct 10. No abstract available.
PubMed 33037882Dale CM, Rose L, Carbone S, Pinto R, Smith OM, Burry L, Fan E, Amaral ACK, McCredie VA, Scales DC, Cuthbertson BH. Effect of oral chlorhexidine de-adoption and implementation of an oral care bundle on mortality for mechanically ventilated patients in the intensive care unit (CHORAL): a multi-center stepped wedge cluster-randomized controlled trial. Intensive Care Med. 2021 Nov;47(11):1295-1302. doi: 10.1007/s00134-021-06475-2. Epub 2021 Oct 5.
PubMed 34609548Aktan GG, Eser I, Uyar M. Effect of an oral care bundle on salivary pH, dry mouth and ventilator-associated pneumonia in intubated patients: a randomized controlled trial. BMC Oral Health. 2026 Jun 3;26(1):1028. doi: 10.1186/s12903-026-08716-6.
PubMed 42237271
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Care Bundle Application on Salivary pH (Power of Hydrogen), Dry Mouth and Ventilator-associated Pneumonia in Intubated Patients
- ClinicalTrials.gov ID
- NCT06258603
- Acronym / sponsor ID
- 19-5T/40
- Conditions
- Pneumonia, Mechanical Ventilation Complication, Salivation, Dry Mouth
- Keywords
- oral health, oral care, intensive care, nursing, intubation, dry mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 14 Feb 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.
The aim of the research was to examine the effect of oral care bundle application on oral health, salivary pH (power of hydrogen), dry mouth and ventilator associated pneumonia in intubated patients compared to standard oral care.
Detailed description
Maintaining the integrity of the oral mucosa in intensive care unit patients is very important due to its close relationship with systemic health, disease risk and self-image, as well as comfort and nutrition. Serious problems develop in patients who have no or insufficient saliva movement or production, are unconscious, or have an artificial airway. Oral health problems, which begin with the deterioration of the saliva flow and content of intubated patients, lead to much more risky and costly situations that end in ventilator associated pneumonia. In the literature, it is seen that oral care practices performed in accordance with protocols increase the risk of complications and that bundle care practices used in different care areas increase the performance of care.In this randomized controlled study, people who were aged between 18 and 70, had received mechanical ventilation support, were intubated orally and in the first 24 hours of intubation, and had a stable hemodynamic status were included in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The randomization of the study was achieved by the faculty member of the University's Faculty of Medicine, Department of Biostatistics and Medical Informatics, with the R version 3.1.3 program. First of all, the individuals included in the study were stratified according to two age groups (19-44 years and 45-70 years) in the computer environment. Then, individuals in each age group were included in the experimental and control groups in a balanced manner using the block randomization method. The randomization list was hidden from the researcher and the patient and was given to the researcher by a third party during the application. Eligibility and randomization assessment was performed by a critical care nurse independent of the study.
| Arm | Type | Receives |
|---|---|---|
| Patients who received oral care bundle | Experimental | Other: oral care bundle"A oral care bundle" protocol created by the researchers and it was applied by a researcher to experimental group. |
| Patients receiving routine clinical oral care | Other | Other: clinical oral careRoutine oral care protocol used in intensive care unit was applied to control group by the patient's primary nurse. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- mechanical ventilation support,
- orally intubation
- in the first 24 hours of intubation,
- stable hemodynamic status
Key exclusion criteria (8 listed)
- pneumonia
- Sjögren's Syndrome,
- radiotherapy and/or chemotherapy,
- oral care contraindications,
- head and neck trauma,
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 |
|---|---|---|
| oral care bundleIn the first stage, oral health was evaluated and data about the patient was collected. In the second stage, an oral care bundle containing an oral care combination was applied to the experimental group. According to this bundle application, patients were received tooth brushing (with chlorhexidine solution) and ice water application twice a day and moisturizing attempts 4 times a day. In the 3rd stage, saliva pH, dry mouth (amount of salivation) and ventilator associated pneumonia development status of the experimental group patients were evaluated. Measurements were made by the researcher using the Bedside Oral Exam scale, pH (power of hydrogen) strip and Schirmer Tear Test Strip. Data regarding whether patients were diagnosed with ventilator associated pneumonia were obtained from the Infection Control Committee. | Other | Patients who received oral care bundle |
| clinical oral careIn the first stage, oral health was evaluated and data about the patient was collected. In the second stage, routine oral care protocol used in intensive care unit was applied to patients by the patients' primary nurse. According to this application, patients were received oral care using tongue depressor with wrapped in gauze and chlorhexidine solution 4 times a day. In the 3rd stage, saliva pH (power of hydrogen), dry mouth (amount of salivation) and ventilator associated pneumonia development status of the experimental group patients were evaluated. Measurements were made by the researcher using the Bedside Oral Exam scale, pH (power of hydrogen) strip and Schirmer Tear Test Strip. Data regarding whether patients were diagnosed with ventilator associated pneumonia were obtained from the Infection Control Committee. | Other | Patients receiving routine clinical oral care |
Primary outcome
Individual Identification Form
Time frame: First day of data collection
The form was prepared by the researcher in line with literature information. It consists of 9 questions covering the characteristics of the patients (demographic characteristics, diagnoses, APACHE II scores, Glasgow Coma Scale score, rules, feeding patterns, intubation tube number).
Bedside Oral Exam Scale
Time frame: Evaluated for five days.
Oral health was assessed using the scale. The scale consists of 8 subheadings (swallowing, lips, tongue, saliva, mucous membranes, gums, teeth or dentures, and smell). The scale score ranges from 8 points (perfect oral health) to 24 points (impaired oral health).
In this outcome measure, the patients'vsaliva pH (power of hydrogen) was evaluated.
Time frame: The 1st, 3rd and 5th days of oral care practices
Merck brand Universal pH 0-14 indicator was used to measure the saliva pH of the patients. The indicator was placed on the tongue and waited for 1 minute, and the resulting color change was compared with the color scale on the box. According to the literature, the average pH of unstimulated saliva has been determined to be approximately 6.8.
In this outcome measure, the patients' saliva amount was evaluated.
Time frame: The 1st, 3rd and 5th days of oral care practices.
Schirmer Tear Test Strip was used in the application. The Modified Schirmer Test strip was placed under the tongue by holding its end with forceps, and after waiting for 3 minutes, the mm value of the wetness on the strip was read.
In this outcome measure, it was evaluated whether ventilator-associated pneumonia occured in patients receiving care.
Time frame: Evaluated for five days.
To avoid bias regarding the method used, the diagnosis of ventilator associated pneumonia was made independently by the treatment team. In the Intensive Care Unit of Ege University Faculty of Medicine, Department of Anesthesiology and Reanimation, the diagnosis of ventilator associated pneumonia is made by the physician using the nosocomial infection diagnostic criteria of The Centers for Disease Control and Prevention (CDC). Information about the development of ventilator associated pneumonia was obtained from the infection control nurse.
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 15 Feb 2024.
- Background: PubMed 34855285Abdelhafez AI, Tolba AA. Nurses' practices and obstacles to oral care quality in intensive care units in Upper Egypt. Nurs Crit Care. 2023 May;28(3):411-418. doi: 10.1111/nicc.12736. Epub 2021 Dec 2.
- Background: PubMed 30499786Alja'afreh MA, Mosleh SM, Habashneh SS. The Effects of Oral Care Protocol on the Incidence of Ventilation-Associated Pneumonia in Selected Intensive Care Units in Jordan. Dimens Crit Care Nurs. 2019 Jan/Feb;38(1):5-12. doi: 10.1097/DCC.0000000000000334.
- Background: PubMed 10401348Andersson P, Persson L, Hallberg IR, Renvert S. Testing an oral assessment guide during chemotherapy treatment in a Swedish care setting: a pilot study. J Clin Nurs. 1999 Mar;8(2):150-8. doi: 10.1046/j.1365-2702.1999.00237.x.
- Background: PubMed 35037992Blot S, Deschepper M, Labeau S. De-adoption of chlorhexidine oral care and ICU mortality. Intensive Care Med. 2022 May;48(5):624-625. doi: 10.1007/s00134-022-06621-4. Epub 2022 Jan 17. No abstract available.
- Background: PubMed 31248697Chair SY, Chan DWK, Cao X. The interaction of subglottic drainage, cuff pressure, and oral care on endotracheal tube fluid leakage: A benchtop study. Aust Crit Care. 2020 Jul;33(4):358-363. doi: 10.1016/j.aucc.2019.05.002. Epub 2019 Jun 24.
- Background: PubMed 33037882Cuthbertson BH, Dale CM. Less daily oral hygiene is more in the ICU: yes. Intensive Care Med. 2021 Mar;47(3):328-330. doi: 10.1007/s00134-020-06261-6. Epub 2020 Oct 10. No abstract available.
- Background: PubMed 34609548Dale CM, Rose L, Carbone S, Pinto R, Smith OM, Burry L, Fan E, Amaral ACK, McCredie VA, Scales DC, Cuthbertson BH. Effect of oral chlorhexidine de-adoption and implementation of an oral care bundle on mortality for mechanically ventilated patients in the intensive care unit (CHORAL): a multi-center stepped wedge cluster-randomized controlled trial. Intensive Care Med. 2021 Nov;47(11):1295-1302. doi: 10.1007/s00134-021-06475-2. Epub 2021 Oct 5.
- Derived from this study: PubMed 42237271Aktan GG, Eser I, Uyar M. Effect of an oral care bundle on salivary pH, dry mouth and ventilator-associated pneumonia in intubated patients: a randomized controlled trial. BMC Oral Health. 2026 Jun 3;26(1):1028. doi: 10.1186/s12903-026-08716-6.
- Individual participant dataSharing planned: No. It will be shared after the article is published
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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 oral care bundle and clinical oral care in people with Pneumonia and Mechanical Ventilation Complication, run by Nigde Omer Halisdemir 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 4 inclusion and 8 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 15 Feb 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?
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?
Individual Identification Form (time frame: First day of data collection). 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?
On the ClinicalTrials.gov record for NCT06258603, which also lists 8 linked publications.
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 15 Feb 2024.