Continuous Exhaled Breath Condensate pH in Mechanically Ventilated Patients
Primary Purpose
Respiratory Distress Syndrome, Adult, Respiratory Syncytial Virus Infections, Pneumonia
Status
Unknown status
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Respiratory Distress Syndrome, Adult focused on measuring EBC pH, Airway acidification, Condensimetry, ARDS, RSV, ALI, Airway reconstruction
Eligibility Criteria
Inclusion Criteria:
- Any intubated patients, aged birth to adulthood, who are on a ventilator in any University of Virginia (UVA) intensive care unit.
Exclusion Criteria:
- Control subjects may not be taking oral or inhaled steroids or have asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, bacterial or viral pneumonitis, or adult respiratory distress syndrome (ARDS).
Sites / Locations
- University of VirginiaRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00429637
First Posted
January 30, 2007
Last Updated
August 6, 2008
Sponsor
University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT00429637
Brief Title
Continuous Exhaled Breath Condensate pH in Mechanically Ventilated Patients
Official Title
Phase 2 Continuous Exhaled Breath Condensate pH in Mechanically Ventilated Patients
Study Type
Observational
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Virginia
4. Oversight
5. Study Description
Brief Summary
Given the possible prognostic relationship between exhaled breath condensate pH and clinical symptoms, it is quite plausible that exhaled breath condensate pH can prove useful in the intensive care unit. For example, if exhaled breath condensate pH falls prior to the onset of clinical symptoms, it is likely that it can be useful as an early marker, heralding the onset of various inflammatory lung diseases. Specifically, exhaled breath condensate pH could be used as a safe, non-invasive screening tool for Ventilator Associated Pneumonia. Similarly, just as changes in exhaled breath condensate pH might predict the onset of disease, exhaled breath condensate pH changes might also mark the progression or resolution of disease (e.g. alerting clinicians to possible readiness for extubation). Although such notions are hypothetical, they are beginning to be supported by anecdotal evidence.
Detailed Description
The investigators have developed a method of collecting exhaled breath condensate pH continually from ventilated patients, which (1) takes samples from an exhaust port on the outside of the ventilator circuit, and (2) possesses no measurable resistance to the ventilator circuit (and, therefore the sampling procedure in no way affects the patient).
Now, additionally, we have performed the continuous collection process on 10 patients in the intensive care units, none of whom have had any ill effects from the collection process.
The placement of the exhaled breath condensate collection device on the ventilator exhaust port offers a simplified, accurate, and safe method of investigating the relationships between airway pH and various pulmonary inflammatory disease processes in intubated patients of all ages.
In order to further extend our study of airway pH in intubated subjects, we believe it is necessary to obtain more frequent exhaled breath condensate pH measurements from intubated subjects. To that end, we have developed a collection system that will also measure the pH of the collected exhaled breath condensate in a fashion similar to the methodology used for thousands of assays in our laboratory and other laboratories globally. This involves deaeration of the sample to remove carbon dioxide. In the lab environment, this is performed with Argon. In the ICU setting, we will accomplish the same effect by using wall oxygen.
The continuous exhaled breath condensate pH collection and assay system consists of a condenser attached to the exhaust port of the ventilator. The condenser is kept chilled to slightly above freezing temperature by a refrigeration system commonly employed in ICU settings. The collection device stays attached to the exhalation port of the ventilator continuously, for hours to days.
Collected exhaled breath condensate is channeled into two deaeration chambers, through which wall oxygen is bubbled (total flow of 1 liter/min). In the second deaeration chamber, a micro pH electrode is inserted. This pH electrode is attached to a pH recorder that has internal memory that can record essentially an infinite number of measurements, allowing for any length duration of monitoring. This recorder has been evaluated by clinical engineering for radio frequency and other interference and is cleared for hospital use.
After measurement of pH, exhaled breath condensate is channeled into a waste chamber.
The breath condensate collection system is maintained chilled by a "hospital grade" Electri-Cool II model 767 refrigerated cooling system (or near-equivalent) that is clinically approved for use in the intensive care units. This device is approximately 30 cm on a side, and is kept on a wheeled cart out of the way of any clinical activity.
Hypothesis to be Tested: Clearly state the objectives and hypotheses and clearly define the primary and any secondary outcome measures.
Exhaled breath condensate pH will have greater within-hour variability in subjects with lung disease than in subjects intubated for non-pulmonary reasons.
Exhaled breath condensate pH will rise prior to readiness for extubation in infants and toddlers requiring mechanical ventilation for acute bronchiolitis.
A decline in exhaled breath condensate pH or an increase in exhaled breath condensate pH variability will predict the onset of pulmonary inflammatory processes (such as ventilator-associated pneumonia) in those who initially require mechanical ventilation for non-inflammatory reasons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Adult, Respiratory Syncytial Virus Infections, Pneumonia, Acute Lung Injury
Keywords
EBC pH, Airway acidification, Condensimetry, ARDS, RSV, ALI, Airway reconstruction
7. Study Design
Enrollment
120 (Anticipated)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any intubated patients, aged birth to adulthood, who are on a ventilator in any University of Virginia (UVA) intensive care unit.
Exclusion Criteria:
Control subjects may not be taking oral or inhaled steroids or have asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, bacterial or viral pneumonitis, or adult respiratory distress syndrome (ARDS).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian K Walsh, BS, RRT
Phone
434-243-9324
Email
bkw2j@virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John F Hunt, MD
Phone
434-243-9324
Email
jhunt@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F Hunt, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian K Walsh, BS, RRT
Phone
434-243-9324
Email
bkw2j@virginia.edu
First Name & Middle Initial & Last Name & Degree
John F Hunt, MD
Phone
434-243-9324
Email
jhunt@virginia.edu
12. IPD Sharing Statement
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Continuous Exhaled Breath Condensate pH in Mechanically Ventilated Patients
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