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Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants

Primary Purpose

Pneumonia, Ventilator-Associated

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
supine positioning
lateral positioning
Sponsored by
Cairo University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pneumonia, Ventilator-Associated focused on measuring Gravity, Mechanical ventilation, Infants, Ventilator-associated pneumonia, Types of bacterial colonies in subjects at 2-5 days of mechanical ventilation, Colony count of an organism was cultured

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Term and premature infants >28 weeks of gestation
  • Postnatal age <48 hours
  • Mechanical ventilation >5 days

Exclusion Criteria:

  • Congenital infections
  • Congenital pneumonia
  • Congenital anomalies such as tracheal-esophageal fistula, thoracic cage deformities and diaphragmatic hernia
  • not maintained on mechanical ventilation for 5 complete days

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Rate of colonization in tracheal aspirates at 2 days

    Secondary Outcome Measures

    Number of colonies in colonized infants

    Full Information

    First Posted
    June 25, 2007
    Last Updated
    June 25, 2007
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00491660
    Brief Title
    Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Cairo University

    4. Oversight

    5. Study Description

    Brief Summary
    Ventilator-associated pneumonia (VAP) is the leading cause of death among all nosocomial infections in ventilated patients. Once intubated, the risk of pneumonia in hospitalized patients is increased 3-10 fold; almost 90% of hospital-acquired pneumonia occurs in intubated patients. Each episode of VAP is associated with 7-9 days of additional hospital stay with an estimated increase in cost of care that exceeds $40,000. In an effort to control VAP, several studies were conducted including oral and gastric decontamination with antibiotics, rotation of the bed, and local instillation of antibiotics via endotracheal tube. Despite such efforts, VAP is still a major complication for intubated patients. The effect of gravity on bacterial colonization of the endotracheal tube was recently explored in an animal study that was conducted at the United States National Institutes of Health. The study demonstrated a significantly lower tracheal colonization and decreased alveolar contamination in ventilated sheep when positioned on their side allowing for tracheal drainage by gravity. Such findings have not been validated in clinical practice and the need for clinical trials studying the effect of lateral positioning have been demanded. Therefore, we aimed our randomized controlled trial to test the hypothesis that intubated infants who are positioned on their side are at lower risk for contracting microbes in their trachea when compared to those in a supine position.
    Detailed Description
    Subjects were to be randomly assigned to one of two groups: Supine group, in which infants are maintained on their back at all times. The endotracheal tube is held upright in vertical position at all times. The bed is kept horizontal without any angle or tilt. Lateral group. Infants are maintained on their side while the back supported with a rolled towel. The endotracheal tube is maintained to rest horizontally on the bed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia, Ventilator-Associated
    Keywords
    Gravity, Mechanical ventilation, Infants, Ventilator-associated pneumonia, Types of bacterial colonies in subjects at 2-5 days of mechanical ventilation, Colony count of an organism was cultured

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    supine positioning
    Intervention Type
    Behavioral
    Intervention Name(s)
    lateral positioning
    Primary Outcome Measure Information:
    Title
    Rate of colonization in tracheal aspirates at 2 days
    Time Frame
    2 days
    Secondary Outcome Measure Information:
    Title
    Number of colonies in colonized infants
    Time Frame
    5 days

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    48 Hours
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Term and premature infants >28 weeks of gestation Postnatal age <48 hours Mechanical ventilation >5 days Exclusion Criteria: Congenital infections Congenital pneumonia Congenital anomalies such as tracheal-esophageal fistula, thoracic cage deformities and diaphragmatic hernia not maintained on mechanical ventilation for 5 complete days
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Magda Badawy, MD
    Organizational Affiliation
    Cairo University Children's Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Afaf Mohamed, M.B,B.Ch
    Organizational Affiliation
    Cairo University Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants

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