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Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants

This study has been completed.
Sponsor:
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT00491660
First received: June 25, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 25, 2007
June 25, 2007
January 2005
Not Provided
Rate of colonization in tracheal aspirates at 2 days [ Time Frame: 2 days ]
Same as current
No Changes Posted
Number of colonies in colonized infants [ Time Frame: 5 days ]
Same as current
Not Provided
Not Provided
 
Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants
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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.

Subjects were to be randomly assigned to one of two groups:

  1. 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.
  2. 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Supportive Care
Pneumonia, Ventilator-Associated
  • Behavioral: supine positioning
  • Behavioral: lateral positioning
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2006
Not Provided

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
Both
up to 48 Hours
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00491660
2004-MD-Thesis-Afaf
Not Provided
Not Provided
Cairo University
Not Provided
Study Chair: Magda Badawy, MD Cairo University Children's Hospital
Principal Investigator: Afaf Mohamed, M.B,B.Ch Cairo University Children's Hospital
Cairo University
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP