Ventilator Associated PneumoniaNCT04397952
Endotracheal Tube Cuff Pressure Measurement
An observational study of Ventilator Associated Pneumonia and Morality, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The effect of endotracheal cuff pressure measurement technique for preventing ventilatory associated pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ventilator Associated Pneumonia, Morality, Trauma, Brain
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 1 Jan 2020
- How long will I take part?
- 5 Days
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who followed up in a tertiary intensive care unit diagnosed with traumatic brain injury and under mechanical ventilation.
Who may be able to join
- Patients with ASA classification of 1 - 2- 3 patients Patients required mechanical ventilation support for more than 48 hours Patients diagnosed with Traumatic brain injury
Who cannot join
- Official patient relatives who rejected to give informed consent for the study Patients diagnosed with aspiration pneumonia during ICU follow up Patients diagnosed with Acute Respiratory Distress Syndrome Patients diagnosed with cavitary lung lesion Primary lung cancer Metastatic lung cancer Congenitally immune deficiency Leukopenia Neutropenia Tracheostomized patients Post cardiopulmonary arrest patients Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training and Research Hospital
Istanbul, 34200
About this study
Official title: Comparison of Two Different Measurement of Endotracheal Tube Cuff Pressure for Ventilatory Associated Pnemonia in Severe Brain Injured Patients
The effect of endotracheal cuff pressure measurement technique for preventing ventilatory associated pneumonia.
Read the detailed description
Aim of this study is to evaluate the effect of endotracheal cuff pressure measurement technique for preventing ventilatory associated pneumonia of severe traumatic brain injured patients in a tertiary level intensive care unit.
- Keywords
- pneumonia, cuff pressure, brain injury
- Medical subject headings
- Pneumonia, Ventilator-Associated, Brain Injuries, Traumatic, Pneumonia, Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration
Follow up duration in ICU
Measured: 30 days
Ventilation
Mechanically ventilated period
Measured: 30 days
Score
Clinical Pulmonary Infection Score Change from baseline at 48.hour, 72.hour and 96.hour
Measured: 48.hour - 72.hour - 96.hour
CRP
C Reactive Protein measurement change from Baseline at 48.hour, 72.hour and 96.hour
Measured: 48.hour - 72.hour - 96.hour
Oxygenation
Fractional Inspiratory Oxygen levels change from baseline at 48.hour, 72.hour and 96.hour
Measured: 48.hour - 72.hour - 96.hour
PEEP
Positive End Expiratory Pressure levels change from baseline at 48.hour, 72.hour and 96.hour during ventilatory support
Measured: 48.hour - 72.hour - 96.hour
Secondary outcomes (3)
Tracheal aspirate
Tracheal aspirate sample for culture
Measured: 0.hour - 48.hour - 72.hour - 96.hour
Bacterial distribution
Bacterial distribution of tracheal aspirate culture
Measured: 0.hour - 48.hour - 72.hour - 96.hour
Mortality
Total mortality ratio during study period
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Nov 2017
- Primary completion15 Apr 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Salih SS Sevdi, MD, Principal investigator, Univesity of Health Sciences Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397952
- Sponsor's protocol ID
- 2017.11.1.02.008.r1.010
- Status last verified
- May 2020
- First submitted
- 20 Jan 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Measurement of Endotracheal Tube Cuff Pressure for Ventilatory Associated Pnemonia in Severe Brain Injured Patients
- ClinicalTrials.gov ID
- NCT04397952
- Acronym / sponsor ID
- 2017.11.1.02.008.r1.010
- Keywords
- pneumonia, cuff pressure, brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 21 May 2020 (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 effect of endotracheal cuff pressure measurement technique for preventing ventilatory associated pneumonia.
Detailed description
Aim of this study is to evaluate the effect of endotracheal cuff pressure measurement technique for preventing ventilatory associated pneumonia of severe traumatic brain injured patients in a tertiary level intensive care unit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who followed up in a tertiary intensive care unit diagnosed with traumatic brain injury and under mechanical ventilation.
Key inclusion criteria (1 listed)
- Patients with ASA classification of 1 - 2- 3 patients Patients required mechanical ventilation support for more than 48 hours Patients diagnosed with Traumatic brain injury
Key exclusion criteria (1 listed)
- Official patient relatives who rejected to give informed consent for the study Patients diagnosed with aspiration pneumonia during ICU follow up Patients diagnosed with Acute Respiratory Distress Syndrome Patients diagnosed with cavitary lung lesion Primary lung cancer Metastatic lung cancer Congenitally immune deficiency Leukopenia Neutropenia Tracheostomized patients Post cardiopulmonary arrest patients Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration
Time frame: 30 days
Follow up duration in ICU
Ventilation
Time frame: 30 days
Mechanically ventilated period
Score
Time frame: 48.hour - 72.hour - 96.hour
Clinical Pulmonary Infection Score Change from baseline at 48.hour, 72.hour and 96.hour
CRP
Time frame: 48.hour - 72.hour - 96.hour
C Reactive Protein measurement change from Baseline at 48.hour, 72.hour and 96.hour
Oxygenation
Time frame: 48.hour - 72.hour - 96.hour
Fractional Inspiratory Oxygen levels change from baseline at 48.hour, 72.hour and 96.hour
PEEP
Time frame: 48.hour - 72.hour - 96.hour
Positive End Expiratory Pressure levels change from baseline at 48.hour, 72.hour and 96.hour during ventilatory support
3 secondary outcomes
Tracheal aspirate
Time frame: 0.hour - 48.hour - 72.hour - 96.hour
Bacterial distribution
Time frame: 0.hour - 48.hour - 72.hour - 96.hour
Mortality
Time frame: 30 days
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 21 May 2020.
- Individual participant dataSharing planned: Undecided
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Not yet recruitingPhase 3
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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.
Salih SS Sevdi, MD principal investigator
Univesity of Health Sciences Bagcilar Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia and Morality, run by Bagcilar Training and Research Hospital 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: finished, as of the sponsor's last update on 21 May 2020. 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?
Duration (time frame: 30 days). The study lists 6 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 21 May 2020.