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

NCT04323150 | Completed

• 1 other identifier: CSS-VAP-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Traumatic Brain Injury; Pancreatic Diseases; Trauma Injury; Seizures; Encephalitis; Abdominal Sepsis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Organ dysfunction

  Change from Baseline SOFA at 96 hours

• Mortality

  28 days

• C - reactive protein

  Change from Baseline CRP researching at 96 hours

• Procalcitonin

  Change from Baseline CRP researching at 96 hours

• sTREM 1

  Change from Baseline CRP researching at 96 hours

Study Arms (2)

Closed suction systems

EXPERIMENTAL

Device: Closed suction systems

Open (conventional) suction

OTHER

control group

Device: Conventional suction system

Interventions

Closed suction systems DEVICE

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

Closed suction systems

Conventional suction system DEVICE

The using of open (conventional) suctioning

Open (conventional) suction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• invasive mechanical ventilation beyond 48 hours

You may not qualify if:

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

Sponsors & Collaborators

• Northern State Medical University: lead

Study Sites (1)

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

Severodvinsk, 164522, Russia

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Pancreatic Diseases; Accidental Injuries; Seizures; Encephalitis; Intraabdominal Infections

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Department of Anaesthesiology and Intensive Care Medicine, MD, PhD

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: March 26, 2020
• Study Start: February 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

RU (1)