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

Seizures Clinical Trial

— CSS-VAP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04323150
• Other study ID #: CSS-VAP-1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2022
• Source: Northern State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• invasive mechanical ventilation beyond 48 hours

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Abdominal Sepsis
• Brain Injuries
• Brain Injuries, Traumatic
• Encephalitis
• Intraabdominal Infections
• Pancreatic Diseases
• Pneumonia
• Pneumonia, Ventilator-Associated
• Seizures
• Severe Traumatic Brain Injury
• Trauma Injury
• Wounds and Injuries

Intervention

Device:
• Closed suction systems
Closed suction systems are using for prevention of the ventilator-associated pneumoniae
• Conventional suction system
The using of open (conventional) suctioning

Locations

Country	Name	City	State
Russian Federation	State Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"	Severodvinsk

Sponsors (1)

Lead Sponsor	Collaborator
Northern State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of the ventilator - associated pneumoniae (VAP)	Assessment of CPIS, if CPIS equal or more 6 points VAP will be observed	Change from Baseline CPIS at 96 hours
Primary	Contamination of closet inanimate surfaces	Microbiology researching samples from circuit of a respirator and a bed	Change from Baseline Microbiology researching at 96 hours
Secondary	Organ dysfunction	Patient examination with Sequential Organ Function Assessment (SOFA)	Change from Baseline SOFA at 96 hours
Secondary	Mortality	Mortality for 28 days of a hospitalization	28 days
Secondary	C - reactive protein	Investigation of a Biomarker of the VAP	Change from Baseline CRP researching at 96 hours
Secondary	Procalcitonin	Investigation of a Biomarker of the VAP	Change from Baseline CRP researching at 96 hours
Secondary	sTREM 1	Investigation of a Biomarker of the VAP	Change from Baseline CRP researching at 96 hours