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Completed

NCT Number: NCT04323150

The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia.

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.

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Key information

Conditions

Severe Traumatic Brain Injury Abdominal Sepsis Accidental Injuries Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Digestive System Diseases Encephalitis Infections Intraabdominal Infections Nervous System Diseases Neuroinflammatory Diseases Neurologic Manifestations Pancreatic Diseases Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Trauma Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"

Severodvinsk, 164522, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • invasive mechanical ventilation beyond 48 hours

Exclusion criteria

  • hospital - acquired pneumonia
  • community - acquired pneumoniae
  • BMI > 35 kg/cm2
  • pregnancy
  • tracheostomy

Treatment and study plan

Closed suction systems

Device

Closed suction systems are using for prevention of the ventilator-associated pneumoniae

Conventional suction system

Device

The using of open (conventional) suctioning

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Organ dysfunction

    Time frame: Change from Baseline SOFA at 96 hours

    Patient examination with Sequential Organ Function Assessment (SOFA)

  2. Mortality

    Time frame: 28 days

    Mortality for 28 days of a hospitalization

  3. C - reactive protein

    Time frame: Change from Baseline CRP researching at 96 hours

    Investigation of a Biomarker of the VAP

  4. Procalcitonin

    Time frame: Change from Baseline CRP researching at 96 hours

    Investigation of a Biomarker of the VAP

  5. sTREM 1

    Time frame: Change from Baseline CRP researching at 96 hours

    Investigation of a Biomarker of the VAP

Sponsors and collaborators

Lead sponsor

Northern State Medical University

Other

Registry information

Official study 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.

Acronym: CSS-VAP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2020
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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