Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants

NCT00491660 | Completed

• 1 other identifier: 2004-MD-Thesis-Afaf
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Rate of colonization in tracheal aspirates at 2 days

  2 days

Secondary Outcomes (1)

• Number of colonies in colonized infants

  5 days

Interventions

supine positioning BEHAVIORAL

lateral positioning BEHAVIORAL

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Magda Badawy, MD

  Cairo University Children's Hospital

  STUDY CHAIR

• Afaf Mohamed, M.B,B.Ch

  Cairo University Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 26, 2007
• Study Start: January 1, 2005
• Study Completion: July 1, 2006
• Last Updated: June 26, 2007

Record last verified: 2007-06