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Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants

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ClinicalTrials.gov Identifier: NCT00491660
Recruitment Status : Completed
First Posted : June 26, 2007
Last Update Posted : June 26, 2007
Sponsor:
Information provided by:
Cairo University

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.


Condition or disease Intervention/treatment Phase
Pneumonia, Ventilator-Associated Behavioral: supine positioning Behavioral: lateral positioning Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Supportive Care
Study Start Date : January 2005
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources




Primary Outcome Measures :
  1. Rate of colonization in tracheal aspirates at 2 days [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Number of colonies in colonized infants [ Time Frame: 5 days ]


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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491660


Sponsors and Collaborators
Cairo University
Investigators
Study Chair: Magda Badawy, MD Cairo University Children's Hospital
Principal Investigator: Afaf Mohamed, M.B,B.Ch Cairo University Children's Hospital

ClinicalTrials.gov Identifier: NCT00491660     History of Changes
Other Study ID Numbers: 2004-MD-Thesis-Afaf
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: June 26, 2007
Last Verified: June 2007

Keywords provided by Cairo University:
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

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury