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
  Purpose

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 Intervention
Pneumonia, Ventilator-Associated
Behavioral: supine positioning
Behavioral: lateral positioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Cairo University:

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

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

Enrollment: 60
Study Start Date: January 2005
Study Completion Date: July 2006
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.
  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00491660     History of Changes
Other Study ID Numbers: 2004-MD-Thesis-Afaf
Study First Received: June 25, 2007
Last Updated: June 25, 2007
Health Authority: Egypt: Ministry of Health and Population

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

ClinicalTrials.gov processed this record on September 22, 2014