Futility of Exhaled Breath Condensate pH Measurements in Ventilated Patients in Intensive Care Unit (ICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01393431
Recruitment Status : Terminated (IRB recommended to stop the trial becasue none of the 4 procedures showed a predictive value for VAP, duration of MV or mortality.)
First Posted : July 13, 2011
Last Update Posted : August 4, 2011
Information provided by:
Universidad Nacional de Rosario

Brief Summary:
Measurement of pH in Exhaled breath condensate has been mentioned as a robust variable from lung inflammation. It is non-invasive and reproducible. The investigators measured pH in the water condensed in the trap of expiratory arm of ventilator.In ICU the investigators measured pH in condensed water without interfering with patients treatment. A group of critically ill patients mechanically ventilated due to non pulmonary cause were followed until successful weaning, death or pneumonia. The investigators found that pH did not change along the study and it did not predict worsening condition.

Condition or disease
Ventilator Associated Pneumonia Death

Detailed Description:
Collection of exhaled breath condensate (EBC) became a promising method for obtaining samples from the lungs. In this prospective clinical trial we aimed to answer if spontaneous EBC in the trap of the expiratory arm of the ventilator could replace EBC collected by coolant chamber with gas standardization with Argon as an inert gas. Second, if EBC pH could predict ventilator associated pneumonia (VAP) and mortality. We included a group of critically ill patients, that required mechanical ventilation due to non-pulmonary cause. The patients were followed up until development of VAP, successful weaning or death.EBC pH spontaneously collected in the trap of expiratory arm of the ventilator. We measured pH with a blood gas analyzer, named Radiometer ABL5 Copenhagen. For the coolant chamber EBC pH measurement, the expiratory arm was passed through the chamber at -3ºC and in 10 min at least 2 ml was collected. The rest of the EBC was collected in Ependorff tube and pH was measured after de-aeration of the condensate with argon (350 ml/min) for 10 min as a gas standardization procedure as previously described by Hunt and colleagues. [Hunt JF, Fang K, Malik R, Snyder A, Malhotra N, Platts-Mills TAE, Gaston B. Endogenous airway acidification: implications for asthma pathophysiology. Am J Resp Crit Care Med 2000; 161: 694-699. ]

Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exhaled Breath Condensate pH in Mechanically Ventilated Patients
Study Start Date : August 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Observational study

Primary Outcome Measures :
  1. Exhaled Breath Condensate (EBC)pH of expiratory trap and Exhaled breath condensate pH obtained with coolant chamber and deaerated with Argon [ Time Frame: follow up during mechanical ventilation, averaged less than 4 weeks ]
    It was an observational study that showed no changes in EBC pH despite different patient´s outcome. We, as investigators, did not make any intervention.

Secondary Outcome Measures :
  1. Exhaled breath condensate pH could predict ventilator associated pneumonia or death [ Time Frame: Follow up during mechanical ventilation (averaged less than 4 weeks) ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults (age >18) Acute critically ill patients that required endotracheal intubation and mechanical ventilation for at least 48 hours due to a non-pulmonary cause.

Inclusion Criteria:

  • Endotracheal intubation and mechanical ventilation for at least 48 hours due to non-pulmonary cause
  • For whom their close acquaintances gave the informed consent

Exclusion Criteria:

  • Pregnancy, denied surrogate decision-makers to give informed consent.
  • Patients that required mechanical ventilation due to: pneumonia, severe respiratory infection, massive haemoptysis, acute severe asthma, bronchiectasis, COPD exacerbation, or acute lung injury. Finally, patients that expected to be ventilated less than 2 days.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01393431

Unidad de Terapia Intensiva. II Cátedra de Clínica Médica y Terapéutica. Universidad Nacional de Rosario. Hospital Escuela "Eva Perón". San Martín 1645.
Granadero Baigorria, Santa Fe, Argentina, 2152
Sponsors and Collaborators
Universidad Nacional de Rosario
Principal Investigator: Luis J Nannini, MD hospital E Perón. UNR. ARGENTINA

Responsible Party: Luis J Nannini= Principal Investigator, Hospital Escuela E Perón & UNR Identifier: NCT01393431     History of Changes
Other Study ID Numbers: EBC pH in ICU
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: May 2008

Keywords provided by Universidad Nacional de Rosario:
Exhaled breath condensate pH
Predictive value of pH

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury