Severe Traumatic Brain InjuryCSS-VAPNCT04323150
The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia.
A study testing Closed suction systems and Conventional suction system in people with Severe Traumatic Brain Injury and Pancreatic Diseases, run by Northern State Medical University at 1 site in Russia.
Trial summary
The investigators are suggesting that closed suction systems may reduce the risk of the ventilator - associated pneumoniae (VAP) and the contamination of the closest unanimated surfaces. In 2011 David et al. have shown that closed suction systems might reduce the incidence of the late VAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Traumatic Brain Injury, Pancreatic Diseases, Trauma Injury
- What is being tested?
- Closed suction systems and Conventional suction system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2018to 31 Dec 2020
- 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
- invasive mechanical ventilation beyond 48 hours
Who cannot join
- hospital - acquired pneumonia
- community - acquired pneumoniae
- BMI > 35 kg/cm2
- pregnancy
- tracheostomy
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"
Severodvinsk, 164522
About this study
Official title: The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia, Respiratory-associated Microbiome and Contamination of Inanimate Surfaces: a Pilot Study.
The investigators are suggesting that closed suction systems may reduce the risk of the ventilator - associated pneumoniae (VAP) and the contamination of the closest unanimated surfaces. In 2011 David et al. have shown that closed suction systems might reduce the incidence of the late VAP. Research team is thinking that preventive bundle with closed suction systems can prevent to onset of the VAP. All enrolled patients is randomizing into two groups: control group - conventional suctioning and research group - suctioning with closed suction system.
- Conditions
- Severe Traumatic Brain Injury, Pancreatic Diseases, Trauma Injury, Seizures, Encephalitis, Abdominal Sepsis
- Being tested
- Closed suction systems, Conventional suction system
- Medical subject headings
- Brain Injuries, Traumatic, Pancreatic Diseases, Accidental Injuries, Seizures, Encephalitis, Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed suction systemsDevice
Closed suction systems are using for prevention of the ventilator-associated pneumoniae
Conventional suction systemDevice
The using of open (conventional) suctioning
| Study group | Role | What they receive |
|---|---|---|
| Closed suction systems | Experimental | Not described Receives: Device: Closed suction systems |
| Open (conventional) suction | Other | control group Receives: Device: Conventional suction system |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of the ventilator - associated pneumoniae (VAP)
Assessment of CPIS, if CPIS equal or more 6 points VAP will be observed
Measured: Change from Baseline CPIS at 96 hours
Contamination of closet inanimate surfaces
Microbiology researching samples from circuit of a respirator and a bed
Measured: Change from Baseline Microbiology researching at 96 hours
Secondary outcomes (5)
Organ dysfunction
Patient examination with Sequential Organ Function Assessment (SOFA)
Measured: Change from Baseline SOFA at 96 hours
Mortality
Mortality for 28 days of a hospitalization
Measured: 28 days
C - reactive protein
Investigation of a Biomarker of the VAP
Measured: Change from Baseline CRP researching at 96 hours
Procalcitonin
Investigation of a Biomarker of the VAP
Measured: Change from Baseline CRP researching at 96 hours
sTREM 1
Investigation of a Biomarker of the VAP
Measured: Change from Baseline CRP researching at 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Feb 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Traumatic Brain InjuryStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vsevolod V. Kuzkov, Northern State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323150
- Sponsor's protocol ID
- CSS-VAP-1
- Acronym
- CSS-VAP
- Status last verified
- Apr 2022
- First submitted
- 21 Mar 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia, Respiratory-associated Microbiome and Contamination of Inanimate Surfaces: a Pilot Study.
- ClinicalTrials.gov ID
- NCT04323150
- Acronym / sponsor ID
- CSS-VAP / CSS-VAP-1
- Conditions
- Severe Traumatic Brain Injury, Pancreatic Diseases, Trauma Injury, Seizures, Encephalitis, Abdominal Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Mar 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 investigators are suggesting that closed suction systems may reduce the risk of the ventilator - associated pneumoniae (VAP) and the contamination of the closest unanimated surfaces. In 2011 David et al. have shown that closed suction systems might reduce the incidence of the late VAP. Research team is thinking that preventive bundle with closed suction systems can prevent to onset of the VAP. All enrolled patients is randomizing into two groups: control group - conventional suctioning and research group - suctioning with closed suction system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed suction systems | Experimental | Device: Closed suction systems |
| Open (conventional) suction | Other | Device: Conventional suction systemcontrol group |
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 beyond 48 hours
Key exclusion criteria (5 listed)
- hospital - acquired pneumonia
- community - acquired pneumoniae
- BMI > 35 kg/cm2
- pregnancy
- tracheostomy
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 |
|---|---|---|
| Closed suction systemsClosed suction systems are using for prevention of the ventilator-associated pneumoniae | Device | Closed suction systems |
| Conventional suction systemThe using of open (conventional) suctioning | Device | Open (conventional) suction |
Primary outcome
incidence of the ventilator - associated pneumoniae (VAP)
Time frame: Change from Baseline CPIS at 96 hours
Assessment of CPIS, if CPIS equal or more 6 points VAP will be observed
Contamination of closet inanimate surfaces
Time frame: Change from Baseline Microbiology researching at 96 hours
Microbiology researching samples from circuit of a respirator and a bed
5 secondary outcomes
Organ dysfunction
Time frame: Change from Baseline SOFA at 96 hours
Mortality
Time frame: 28 days
C - reactive protein
Time frame: Change from Baseline CRP researching at 96 hours
Procalcitonin
Time frame: Change from Baseline CRP researching at 96 hours
sTREM 1
Time frame: Change from Baseline CRP researching at 96 hours
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 8 Apr 2022.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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 Closed suction systems and Conventional suction system in people with Severe Traumatic Brain Injury and Pancreatic Diseases, run by Northern State Medical University at 1 site in Russia.
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 5 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 8 Apr 2022. 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 Russia. 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?
incidence of the ventilator - associated pneumoniae (VAP) (time frame: Change from Baseline CPIS at 96 hours). The study lists 2 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 8 Apr 2022.