Cultures in PICU Patients Compared to Healthy Children

Sponsor
State University of New York at Buffalo (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03418272
Collaborator
(none)
0
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Culture/PCR Analysis

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.

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Oral and Tracheal Cultures in Pediatric ICU Patients Compared to Healthy Children
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Ventilated Pediatric Intensive Care Unit patient Group

This will be a prospective descriptive case series where tracheal cultures and PCR results will be analyzed at initial intubation and again several days into the ICU stay.

Diagnostic Test: Culture/PCR Analysis
Microbes to be selectively cultured and PCR analysis to be conducted. Bacteria obtained in samples will be dispersed in non-selective Mueller Hinton Broth (Sigma-Aldrich), divided into two separate cultures and grown overnight at 37°C in aerobic condition and in 5% CO2 to assure survival of both aerobic and facultative anaerobic species. Staphylococcus aureus (MSSA, MRSA) Pseudomonas aeruginosa Haemophilus influenza Streptococcus pneumonia Streptococcus Pyogenes Group B streptococci, Klebsiella pneumonia Moraxella catarrhalis

Intubated OR patient Control Group

For the healthy operating room children, also a case series where a single set of studies will be obtained. tracheal cultures and PCR results will be analyzed after intubation These two groups will be compared, non-randomized.

Diagnostic Test: Culture/PCR Analysis
Microbes to be selectively cultured and PCR analysis to be conducted. Bacteria obtained in samples will be dispersed in non-selective Mueller Hinton Broth (Sigma-Aldrich), divided into two separate cultures and grown overnight at 37°C in aerobic condition and in 5% CO2 to assure survival of both aerobic and facultative anaerobic species. Staphylococcus aureus (MSSA, MRSA) Pseudomonas aeruginosa Haemophilus influenza Streptococcus pneumonia Streptococcus Pyogenes Group B streptococci, Klebsiella pneumonia Moraxella catarrhalis

Outcome Measures

Primary Outcome Measures

  1. Percentage of bacteria in sample [By January 2019]

    PCR analysis

  2. Presence of bacteria in sample [By January 2019]

    Culture analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 8 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • State University of New York at Buffalo

Investigators

  • Principal Investigator: Christopher Heard, MBChB, FRCA, Jacobs School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christopher Heard, Clinical Professor of Anesthesiology, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT03418272
Other Study ID Numbers:
  • STUDY00001954
First Posted:
Feb 1, 2018
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christopher Heard, Clinical Professor of Anesthesiology, State University of New York at Buffalo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2022