Pneumonia, Ventilator-AssociatedNCT00491660
Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants
A study testing supine positioning and lateral positioning in people with Pneumonia, Ventilator-Associated, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- supine positioning and lateral positioning
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term and premature infants >28 weeks of gestation
- Postnatal age <48 hours
- Mechanical ventilation >5 days
Who cannot join
- 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
About this study
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.
Read the detailed description
Subjects were to be randomly assigned to one of two groups:
- 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.
- 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.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- supine positioning, lateral positioning
- 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
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supine positioningBehavioural
lateral positioningBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of colonization in tracheal aspirates at 2 days
Measured: 2 days
Secondary outcomes (1)
Number of colonies in colonized infants
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startJan 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Investigators
- Magda Badawy, MD, Study chair, Cairo University Children's HospitalAfaf Mohamed, M.B,B.Ch, Principal investigator, Cairo University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491660
- Sponsor's protocol ID
- 2004-MD-Thesis-Afaf
- Status last verified
- Jun 2007
- First submitted
- 25 Jun 2007
- Last updated
- 26 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants
- ClinicalTrials.gov ID
- NCT00491660
- Acronym / sponsor ID
- 2004-MD-Thesis-Afaf
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jul 2006 (actual)
- First posted
- 26 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Term and premature infants >28 weeks of gestation
- Postnatal age <48 hours
- Mechanical ventilation >5 days
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supine positioning | Behavioural | – |
| lateral positioning | Behavioural | – |
Primary outcome
Rate of colonization in tracheal aspirates at 2 days
Time frame: 2 days
1 secondary outcome
Number of colonies in colonized infants
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magda Badawy, MD study chair
Cairo University Children's Hospital
Afaf Mohamed, M.B,B.Ch principal investigator
Cairo University Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing supine positioning and lateral positioning in people with Pneumonia, Ventilator-Associated, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of colonization in tracheal aspirates at 2 days (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2007.