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Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants

NCT00491660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2007-06-26

No results posted yet for this study

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.

Conditions

  • Pneumonia, Ventilator-Associated

Interventions

BEHAVIORAL

supine positioning

BEHAVIORAL

lateral positioning

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Magda Badawy, MD · Cairo University Children's Hospital

  • Afaf Mohamed, M.B,B.Ch · Cairo University Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Completion
2006-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00491660 on ClinicalTrials.gov