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

This study has been terminated.
(IRB recommended to stop the trial becasue none of the 4 procedures showed a predictive value for VAP, duration of MV or mortality.)
Sponsor:
Information provided by:
Universidad Nacional de Rosario
ClinicalTrials.gov Identifier:
NCT01393431
First received: July 1, 2011
Last updated: August 3, 2011
Last verified: May 2008
  Purpose

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
Ventilator Associated Pneumonia
Death

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exhaled Breath Condensate pH in Mechanically Ventilated Patients

Resource links provided by NLM:


Further study details as provided by Universidad Nacional de Rosario:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Exhaled breath condensate pH could predict ventilator associated pneumonia or death [ Time Frame: Follow up during mechanical ventilation (averaged less than 4 weeks) ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: August 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
EBC pH
Observational study

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. ]

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  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: NCT01393431

Locations
Argentina
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
Investigators
Principal Investigator: Luis J Nannini, MD hospital E Perón. UNR. ARGENTINA
  More Information

No publications provided

Responsible Party: Luis J Nannini= Principal Investigator, Hospital Escuela E Perón & UNR
ClinicalTrials.gov Identifier: NCT01393431     History of Changes
Other Study ID Numbers: EBC pH in ICU
Study First Received: July 1, 2011
Last Updated: August 3, 2011
Health Authority: Argentina: Human Research Bioethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014