The Incidence of Ventilator-associated Pneumonia and Rate of Compliance With Survey CriteriaNCT04174274
Investigation of Compliance With Ventilator-Associated Pneumonia Prevention Methods and Incidence of Ventilator-Associated Pneumonia in Intensive Care Units
An observational study of The Incidence of Ventilator-associated Pneumonia and Rate of Compliance With Survey Criteria, run by Diskapi Teaching and Research Hospital.
Trial summary
Ventilator-associated Pneumonia (VAP) is a high-mortality hospital infection that occurs in patients undergoing invasive Mechanical Ventilation (MV) and is frequently encountered in intensive care units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Incidence of Ventilator-associated Pneumonia and Rate of Compliance With Survey Criteria
- What is being tested?
- ventilator-associated pneumonia-developed group followed by mechanical ventilation and not ventilator-associated pneumonia-developed group followed by mechanical ventilation
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Apr 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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
Study population: patients followed up on mechanical ventilation by tracheostomy or endotracheal intubation in ICUs aged 18 and over
Who may be able to join
- patients followed for more than 48 hours on a mechanical ventilator
Who cannot join
- previously diagnosed with pneumonia
- Patients under the age of 18
- Unless lung expansion devices such as cpap, nasal peep, hypo cpap are applied via tracheostomy or endotracheal intubation
- patients due to high frequency ventilation or extracorporeal life support
About this study
Ventilator-associated Pneumonia (VAP) is a high-mortality hospital infection that occurs in patients undergoing invasive Mechanical Ventilation (MV) and is frequently encountered in intensive care units. Prolonged mechanical ventilation, prolonged hospitalizations, excessive use of antibiotics and increased medical costs are seen. Therefore, compliance with ventilator-associated pneumonia prevention methods is becoming increasingly important. Therefore, in the investigator's study was to investigate compliance with ventilator-associated pneumonia prevention methods and the incidence of ventilator-associated pneumonia in intensive care units.
Read the detailed description
In the first stage of the study, Diskapi Yildirim Beyazit Education and Research Hospital Anesthesia Reanimation 1-2-3-4, compliance with ventilator-associated pneumonia prevention rules in neurology, neurosurgery, and internal medicine intensive care units will be investigated. The researcher will visit the intensive care units included in the study twice a day (10:00 and 14:00) by Dr. Gökhan Erdem for 1 week at the same time of day and monitor whether they work in accordance with VAP prevention rules.
VAP prevention methods: Head angle 30-45 degrees, peptic ulcer prophylaxis, thromboembolism prophylaxis, daily wake up test, use of chlorhexidine in oral care, bacterial filter use in ventilator circuit, daily spontaneous breathing trials, silver-coated endotracheal tube use, cuff pressure adequacy, hand hygiene , VAP nurse training, avoiding excessive distension of the stomach, equipment contamination, mechanical tooth cleaning, daily assessment for patient separation from mechanical ventilation, sterile aspiration technique, use of sterile gloves before aspiration, aspiration of subglottic secretions will be recorded.
In the second stage of the study, Diskapi Yildirim Beyazit Education and Research Hospital anesthesia reanimation 1-2-3-4, demographic characteristics of all hospitalized patients for neurological, neurosurgery, and internal medicine intensive care units, reason for hospitalization in intensive care unit, APACHE score, duration of mechanical ventilation, length of stay in ICU unit, blood transfusion, urinary infection, wound infection, presence of infection in at least one site, duration and type of surgery if operated, post-op prophylactic antibiotic use, history of CPR, history of difficult intubation, shape and duration of intubation, presence of tracheostomy , time from intubation to tracheostomy opening, residence time in ICU, change of filters in mechanical ventilator circuits, antibiotic use, low serum albumin value, sedative use, steroid use, feeding type, inotropic requirement, prokinetic agent use, number of bed personnel and nurses, reentubation history, transport history, glaskow coma score, frequency of endotracheal aspiration, peep need, smoking history, nasogastric use, chest tube, central venous catheter, presence of arterial catheter, history of dialysis, continuous infusion therapy, aerosol therapy, chronic diseases will be recorded. Patients under 18 years of age who had previously been diagnosed with pneumonia, lung expansion devices such as cpap, nasal peep, hypocpap were not applied via tracheostomy or endotracheal intubation, and patients due to high frequency ventilation or extracorporeal life support were excluded from VAP surveillance.
- Conditions
- The Incidence of Ventilator-associated Pneumonia and Rate of Compliance With Survey Criteria
- Being tested
- ventilator-associated pneumonia-developed group followed by mechanical ventilation, not ventilator-associated pneumonia-developed group followed by mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilator-associated pneumonia-developed group followed by mechanical ventilationOther
compliance with ventilator-associated pneumonia prevention methods and investigating the incidence of ventilator-associated pneumonia in intensive care units
not ventilator-associated pneumonia-developed group followed by mechanical ventilationOther
compliance with ventilator-associated pneumonia prevention methods and investigating the incidence of ventilator-associated pneumonia in intensive care units
| Study group | Role | What they receive |
|---|---|---|
| positive | ventilator-associated pneumonia-developed group followed by mechanical ventilation Receives: Other: ventilator-associated pneumonia-developed group followed by mechanical ventilation | |
| negative | not ventilator-associated pneumonia-developed group followed by mechanical ventilation Receives: Other: not ventilator-associated pneumonia-developed group followed by mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of ventilator-associated pneumonia incidence in intensive care units
The development of ventilator-associated pneumonia leads to many negative conditions. Therefore, the incidence of ventilator-associated pneumonia is important in terms of decreasing hospital care costs, requiring longer mechanical ventilation, length of hospital stay, mortality and morbidity.
Measured: 01.12.2019-01.03.2020
Secondary outcomes (1)
Investigation of compliance with ventilator-associated pneumonia prevention methods in intensive care units
Compliance with ventilator-related pneumonia prevention rules will be investigated in the intensive care units of Diskapi Yildirim Beyazit Training and Research Hospital.
Measured: 01.12.2019-01.03.2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Incidence of Ventilator-associated Pneumonia and Rate of Compliance With Survey CriteriaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Erdem, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174274
- Sponsor's protocol ID
- VAP incidence and compliance
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 22 Nov 2019
- 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 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Compliance With Ventilator-Associated Pneumonia Prevention Methods and Incidence of Ventilator-Associated Pneumonia in Intensive Care Units
- ClinicalTrials.gov ID
- NCT04174274
- Acronym / sponsor ID
- VAP incidence and compliance
- Conditions
- The Incidence of Ventilator-associated Pneumonia and Rate of Compliance With Survey Criteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 22 Nov 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 a high-mortality hospital infection that occurs in patients undergoing invasive Mechanical Ventilation (MV) and is frequently encountered in intensive care units. Prolonged mechanical ventilation, prolonged hospitalizations, excessive use of antibiotics and increased medical costs are seen. Therefore, compliance with ventilator-associated pneumonia prevention methods is becoming increasingly important. Therefore, in the investigator's study was to investigate compliance with ventilator-associated pneumonia prevention methods and the incidence of ventilator-associated pneumonia in intensive care units.
Detailed description
In the first stage of the study, Diskapi Yildirim Beyazit Education and Research Hospital Anesthesia Reanimation 1-2-3-4, compliance with ventilator-associated pneumonia prevention rules in neurology, neurosurgery, and internal medicine intensive care units will be investigated. The researcher will visit the intensive care units included in the study twice a day (10:00 and 14:00) by Dr. Gökhan Erdem for 1 week at the same time of day and monitor whether they work in accordance with VAP prevention rules.
VAP prevention methods: Head angle 30-45 degrees, peptic ulcer prophylaxis, thromboembolism prophylaxis, daily wake up test, use of chlorhexidine in oral care, bacterial filter use in ventilator circuit, daily spontaneous breathing trials, silver-coated endotracheal tube use, cuff pressure adequacy, hand hygiene , VAP nurse training, avoiding excessive distension of the stomach, equipment contamination, mechanical tooth cleaning, daily assessment for patient separation from mechanical ventilation, sterile aspiration technique, use of sterile gloves before aspiration, aspiration of subglottic secretions will be recorded.
In the second stage of the study, Diskapi Yildirim Beyazit Education and Research Hospital anesthesia reanimation 1-2-3-4, demographic characteristics of all hospitalized patients for neurological, neurosurgery, and internal medicine intensive care units, reason for hospitalization in intensive care unit, APACHE score, duration of mechanical ventilation, length of stay in ICU unit, blood transfusion, urinary infection, wound infection, presence of infection in at least one site, duration and type of surgery if operated, post-op prophylactic antibiotic use, history of CPR, history of difficult intubation, shape and duration of intubation, presence of tracheostomy , time from intubation to tracheostomy opening, residence time in ICU, change of filters in mechanical ventilator circuits, antibiotic use, low serum albumin value, sedative use, steroid use, feeding type, inotropic requirement, prokinetic agent use, number of bed personnel and nurses, reentubation history, transport history, glaskow coma score, frequency of endotracheal aspiration, peep need, smoking history, nasogastric use, chest tube, central venous catheter, presence of arterial catheter, history of dialysis, continuous infusion therapy, aerosol therapy, chronic diseases will be recorded. Patients under 18 years of age who had previously been diagnosed with pneumonia, lung expansion devices such as cpap, nasal peep, hypocpap were not applied via tracheostomy or endotracheal intubation, and patients due to high frequency ventilation or extracorporeal life support were excluded from VAP surveillance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| positive | – | Other: ventilator-associated pneumonia-developed group followed by mechanical ventilationventilator-associated pneumonia-developed group followed by mechanical ventilation |
| negative | – | Other: not ventilator-associated pneumonia-developed group followed by mechanical ventilationnot ventilator-associated pneumonia-developed group followed by mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients followed up on mechanical ventilation by tracheostomy or endotracheal intubation in ICUs aged 18 and over
Key inclusion criteria (1 listed)
- patients followed for more than 48 hours on a mechanical ventilator
Key exclusion criteria (4 listed)
- previously diagnosed with pneumonia
- Patients under the age of 18
- Unless lung expansion devices such as cpap, nasal peep, hypo cpap are applied via tracheostomy or endotracheal intubation
- patients due to high frequency ventilation or extracorporeal life support
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 |
|---|---|---|
| ventilator-associated pneumonia-developed group followed by mechanical ventilationcompliance with ventilator-associated pneumonia prevention methods and investigating the incidence of ventilator-associated pneumonia in intensive care units | Other | positive |
| not ventilator-associated pneumonia-developed group followed by mechanical ventilationcompliance with ventilator-associated pneumonia prevention methods and investigating the incidence of ventilator-associated pneumonia in intensive care units | Other | negative |
Primary outcome
Investigation of ventilator-associated pneumonia incidence in intensive care units
Time frame: 01.12.2019-01.03.2020
The development of ventilator-associated pneumonia leads to many negative conditions. Therefore, the incidence of ventilator-associated pneumonia is important in terms of decreasing hospital care costs, requiring longer mechanical ventilation, length of hospital stay, mortality and morbidity.
1 secondary outcome
Investigation of compliance with ventilator-associated pneumonia prevention methods in intensive care units
Time frame: 01.12.2019-01.03.2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
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?
An observational study of The Incidence of Ventilator-associated Pneumonia and Rate of Compliance With Survey Criteria, run by Diskapi Teaching and Research Hospital.
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 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: status not confirmed, as of the sponsor's last update on 22 Nov 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?
Results are not available in the source record.
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?
Investigation of ventilator-associated pneumonia incidence in intensive care units (time frame: 01.12.2019-01.03.2020). 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 22 Nov 2019.