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
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
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
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
Learn more about this trial
Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants
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