Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 25, 2007 | ||||||||
| Last Updated Date | June 25, 2007 | ||||||||
| Start Date ICMJE | January 2005 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Rate of colonization in tracheal aspirates at 2 days [ Time Frame: 2 days ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Number of colonies in colonized infants [ Time Frame: 5 days ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| 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. |
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| Detailed Description | Subjects were to be randomly assigned to one of two groups:
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Supportive Care |
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| Condition ICMJE | Pneumonia, Ventilator-Associated | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 60 | ||||||||
| Completion Date | July 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 48 Hours | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Not Provided | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00491660 | ||||||||
| Other Study ID Numbers ICMJE | 2004-MD-Thesis-Afaf | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Cairo University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Cairo University | ||||||||
| Verification Date | June 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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