Skip to content

Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00491660
Enrollment
60
Registered
2007-06-26
Start date
2005-01-31
Completion date
2006-07-31
Last updated
2007-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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.

Interventions

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
No minimum to 48 Hours
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Rate of colonization in tracheal aspirates at 2 days2 days

Secondary

MeasureTime frame
Number of colonies in colonized infants5 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026