Continuous Exhaled Breath Condensate pH in Mechanically Ventilated Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Virginia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00429637
First received: January 30, 2007
Last updated: August 6, 2008
Last verified: August 2008
  Purpose

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.


Condition Phase
Respiratory Distress Syndrome, Adult
Respiratory Syncytial Virus Infections
Pneumonia
Acute Lung Injury
Phase 2

Study Type: Observational
Official Title: Phase 2 Continuous Exhaled Breath Condensate pH in Mechanically Ventilated Patients

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Estimated Enrollment: 120
Study Start Date: December 2004
Estimated Study Completion Date: January 2009
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.

  1. Exhaled breath condensate pH will have greater within-hour variability in subjects with lung disease than in subjects intubated for non-pulmonary reasons.
  2. Exhaled breath condensate pH will rise prior to readiness for extubation in infants and toddlers requiring mechanical ventilation for acute bronchiolitis.
  3. 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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429637

Contacts
Contact: Brian K Walsh, BS, RRT 434-243-9324 bkw2j@virginia.edu
Contact: John F Hunt, MD 434-243-9324 jhunt@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Brian K Walsh, BS, RRT    434-243-9324    bkw2j@virginia.edu   
Contact: John F Hunt, MD    434-243-9324    jhunt@virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: John F Hunt, MD University of Virginia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00429637     History of Changes
Other Study ID Numbers: 11618
Study First Received: January 30, 2007
Last Updated: August 6, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
EBC pH
Airway acidification
Condensimetry
ARDS
RSV
ALI
Airway reconstruction

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Respiratory Distress Syndrome, Newborn
Virus Diseases
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014