Ventilator-associated Bacterial PneumoniaNCT04107363
Oropharyngeal Aspiration to Reduce Ventilator-Related Pneumonia
A study testing Oropharyngeal aspiration before changing the position of the patient in people with Ventilator-associated Bacterial Pneumonia, run by Ayşe AKBIYIK.
Trial summary
Ventilator-associated pneumonia (VAP) is one of the healthcare-related infections that is common in critically ill patients, prolongs hospital stay, significantly increases mortality and additional health care costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Bacterial Pneumonia
- What is being tested?
- Oropharyngeal aspiration before changing the position of the patient
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 30 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age,
- Supported mechanical ventilation by endotracheal tube,
- ≥ 24 hours remaining connected to mechanical ventilator,
- Position can be changed every 2 hours during the day and 4 hours at night,
- Patients whose relatives were approved to participate in the study.
Who cannot join
- Pneumonia develops prior to mechanical ventilation support or within the first 48 hours following mechanical ventilation support,
- Positive sputum culture was taken before mechanical ventilation support or within the first 48 hours following mechanical ventilation support,
- Patients with diabetes mellitus,
- Patients with contraindications for routine change of position
About this study
Official title: The Effect of Oropharyngeal Aspiration Before Position Change on Reducing the Incidence of Ventilator-Related Pneumonia
Ventilator-associated pneumonia (VAP) is one of the healthcare-related infections that is common in critically ill patients, prolongs hospital stay, significantly increases mortality and additional health care costs.
Microaspiration of oropharyngeal secretions the primary pathway in the formation of VAP has led researchers to focus on the detection of applications to prevent microbial colonization. Continuous or intermittent oropharyngeal aspiration, open system aspiration versus closed system aspiration, extensive oral care, oropharyngeal aspiration prior to patient positioning are some of these applications.
Read more
When the patient is turned to position, the outbreak accumulated in the oral cavity is more likely to move to the lower respiratory tract. In this study, it is assumed that aspiration of oropharyngeal secretions prior to each position change will reduce the accumulation of oral secretion in the endotracheal tube cuff and reduce aspiration of contaminated secretion and reduce the risk of developing VIP. This randomized controlled experimental study was planned to confirm the validity of this assumption.
This study was a randomized controlled experimental study designed to investigate the effect of oropharyngeal aspiration on decreasing the incidence of ventilator-associated pneumonia in patients receiving mechanical ventilation. The research was conducted between July 2015 and April 2019 in anesthesiology and reanimation intensive care unit. The study was carried out with 20 patients who underwent oropharyngeal aspiration as needed and 20 patients with oropharyngeal aspiration prior to each change of position.
- Being tested
- Oropharyngeal aspiration before changing the position of the patient, Control group:
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oropharyngeal aspiration before changing the position of the patientProcedure or surgery
Patients in the experimental group underwent oropharyngeal aspiration prior to each position change in addition to routine nursing care (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care).
Patients in this group underwent oropharyngeal aspiration at least 9 times in 24 hours with a pressure of 100-120 mmHg for 10 seconds prior to routine (2 hours a day, 4 hours a night) and non-routine position changes. After the oropharyngeal aspiration was completed, the patient's position was changed.
Control group:Other
The patients in the control group received routine nursing care in the unit. (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: | Experimental | Patients in the experimental group underwent oropharyngeal aspiration prior to each position change in addition to routine nursing care (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care).
Patients in this group underwent oropharyngeal aspiration at least 9 times in 24 hours with a pressure of 100-120 mmHg for 10 seconds prior to routine (2 hours a day, 4 hours a night) and non-routine position changes.
After the oropharyngeal aspiration was completed, the patient's position was changed. Receives: Procedure: Oropharyngeal aspiration before changing the position of the patient |
| Control group | Other | The patients in the control group received routine nursing care in the unit. (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care). Receives: Other: Control group: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ventilator-Related Pneumonia
Clinical Pulmonary Infection Score (CPIS) was used in the diagnosis of VAP and, VAP was diagnosed in patients whose CPIS was above 6 in the evaluation. Broncho alveolar lavage specimens were cultured for VAP agent/s. Antibiotic susceptibility of microorganisms grown in positive cultures were investigated.
Measured: Through study completion, about four years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Jul 2015
- Primary completion30 Apr 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-associated Bacterial 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayşe AKBIYIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayşe AKBIYIK, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107363
- Sponsor's protocol ID
- EGE.0.20.05.00/EY/739/924
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oropharyngeal Aspiration Before Position Change on Reducing the Incidence of Ventilator-Related Pneumonia
- ClinicalTrials.gov ID
- NCT04107363
- Acronym / sponsor ID
- EGE.0.20.05.00/EY/739/924
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ayşe AKBIYIKUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 27 Sep 2019 (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 one of the healthcare-related infections that is common in critically ill patients, prolongs hospital stay, significantly increases mortality and additional health care costs.
Microaspiration of oropharyngeal secretions the primary pathway in the formation of VAP has led researchers to focus on the detection of applications to prevent microbial colonization. Continuous or intermittent oropharyngeal aspiration, open system aspiration versus closed system aspiration, extensive oral care, oropharyngeal aspiration prior to patient positioning are some of these applications.
When the patient is turned to position, the outbreak accumulated in the oral cavity is more likely to move to the lower respiratory tract. In this study, it is assumed that aspiration of oropharyngeal secretions prior to each position change will reduce the accumulation of oral secretion in the endotracheal tube cuff and reduce aspiration of contaminated secretion and reduce the risk of developing VIP. This randomized controlled experimental study was planned to confirm the validity of this assumption.
This study was a randomized controlled experimental study designed to investigate the effect of oropharyngeal aspiration on decreasing the incidence of ventilator-associated pneumonia in patients receiving mechanical ventilation. The research was conducted between July 2015 and April 2019 in anesthesiology and reanimation intensive care unit. The study was carried out with 20 patients who underwent oropharyngeal aspiration as needed and 20 patients with oropharyngeal aspiration prior to each change of position.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: | Experimental | Procedure: Oropharyngeal aspiration before changing the position of the patientPatients in the experimental group underwent oropharyngeal aspiration prior to each position change in addition to routine nursing care (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care). Patients in this group underwent oropharyngeal aspiration at least 9 times in 24 hours with a pressure of 100-120 mmHg for 10 seconds prior to routine (2 hours a day, 4 hours a night) and non-routine position changes. After the oropharyngeal aspiration was completed, the patient's position was changed. |
| Control group | Other | Other: Control group:The patients in the control group received routine nursing care in the unit. (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years of age,
- Supported mechanical ventilation by endotracheal tube,
- ≥ 24 hours remaining connected to mechanical ventilator,
- Position can be changed every 2 hours during the day and 4 hours at night,
- Patients whose relatives were approved to participate in the study.
Key exclusion criteria (4 listed)
- Pneumonia develops prior to mechanical ventilation support or within the first 48 hours following mechanical ventilation support,
- Positive sputum culture was taken before mechanical ventilation support or within the first 48 hours following mechanical ventilation support,
- Patients with diabetes mellitus,
- Patients with contraindications for routine change of position
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 |
|---|---|---|
| Oropharyngeal aspiration before changing the position of the patientPatients in the experimental group underwent oropharyngeal aspiration prior to each position change in addition to routine nursing care (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care). Patients in this group underwent oropharyngeal aspiration at least 9 times in 24 hours with a pressure of 100-120 mmHg for 10 seconds prior to routine (2 hours a day, 4 hours a night) and non-routine position changes. After the oropharyngeal aspiration was completed, the patient's position was changed. | Procedure or surgery | Experimental group: |
| Control group:The patients in the control group received routine nursing care in the unit. (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care). | Other | Control group |
Primary outcome
Incidence of Ventilator-Related Pneumonia
Time frame: Through study completion, about four years]
Clinical Pulmonary Infection Score (CPIS) was used in the diagnosis of VAP and, VAP was diagnosed in patients whose CPIS was above 6 in the evaluation. Broncho alveolar lavage specimens were cultured for VAP agent/s. Antibiotic susceptibility of microorganisms grown in positive cultures were investigated.
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 27 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Oropharyngeal aspiration before changing the position of the patient in people with Ventilator-associated Bacterial Pneumonia, run by Ayşe AKBIYIK.
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 5 inclusion and 4 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 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of Ventilator-Related Pneumonia (time frame: Through study completion, about four years]). 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 27 Sep 2019.