Clinical trial NCT03418272: Cultures in PICU Patients Compared to Healthy Children
Official title: Oral and Tracheal Cultures in Pediatric ICU Patients Compared to Healthy Children
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ventilator Associated Pneumonia
Pneumonia, Bacterial
Keywords: ICU
OR
Pneumonia
PICU
Pediatric
PCR
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU Group:

* Intubated within 12 hours
* ASA 1 or 2 (ASA - AMERICAN SOCIETY ANESTEHESIOLOGY PREOPOERATIVE STATUS)
* Age 2 to 8

OR Group:

* ASA 1 or 2
* Elective dental surgery requiring intubation
* Age 2 to 8

Brief summary: This study is being done to determine if the bacteria found in your mouth (oral flora bacteria) in children admitted to the intensive care unit who need to be on a breathing machine is different from the oral flora in healthy children undergoing anesthesia for their dental caries. Children in the intensive care unit with a breathing tube are at a higher risk for getting a lung infection due to the bacteria in the mouth slipping into their lungs past the breathing tube over several days. This means that bacteria are found in the child's lung when this is normally not the case. If the bacteria in the mouth have changed from normal then they may get a pneumonia.

Detailed description: The oral cavity has natural flora of microbiology that may be associated with the development of dental decay. Another possible problem arising from this flora is the migration of the bacteria into the trachea causing pulmonary infections such as trachietis or pneumonia. The risk of developing a pulmonary infection appears to be increased in patients who have been intubated for a period of time (days) such as those patients ventilated in the intensive care unit (ICU). It has also been shown that in patients in the ICU the nature of the oral flora changes over time to include bacteria that are more commonly associated with the nosocomial pneumonia, ventilator associated pneumonia. We have previous demonstrated in a small pilot study (CYIRB2779) that the changes in the oral flora in children intubated in the ICU was similar to those bacteria grown from tracheal cultures ordered by the intensivist. Patients intubated in the ICU maybe at risk of decreased salivary flow, sedated and unable to clear secretions and are reliant on the bedside nurse to maintain adequate oral hygiene. Most ICU's have guidelines and policies to ensure that oral hygiene is appropriately cared for. They are also at risk for changes in the oral flora due to concomitant broad-spectrum antibiotic use that is common in the initial 48 hours after admission with respiratory failure.

The second are of interest is to determine whether children who are very sick and require intubation and ventilation support have different bugs growing in their mouth that may predispose them to future infection whilst in the ICU.

Eligibility criteria: Inclusion Criteria:

ICU Group:

* Intubated within 12 hours
* ASA 1 or 2 (ASA - AMERICAN SOCIETY ANESTEHESIOLOGY PREOPOERATIVE STATUS)
* Age 2 to 8

OR Group:

* ASA 1 or 2
* Elective dental surgery requiring intubation
* Age 2 to 8

Exclusion Criteria:

ICU Group:

* Trauma patients
* Postoperative patients
* Children under 2 or over 8

OR Group:

* Received antibiotics within the last week
* Received prednisone within the last 2 weeks
* Viral respiratory infective process within the last 2 weeks

Primary outcomes:
measure: Percentage of bacteria in sample
timeFrame: By January 2019
measure: Presence of bacteria in sample
timeFrame: By January 2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jacobs School of Medicine
name: Christopher Heard, MBChB, FRCA
role: PRINCIPAL_INVESTIGATOR
References: