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

NCT01393431 | Terminated DMC

• 1 other identifier: EBC pH in ICU
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia; Death

Keywords

Exhaled breath condensate pH; Predictive value of pH

Outcome Measures

Primary Outcomes (1)

• Exhaled Breath Condensate (EBC)pH of expiratory trap and Exhaled breath condensate pH obtained with coolant chamber and deaerated with Argon

  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.

  follow up during mechanical ventilation, averaged less than 4 weeks

Secondary Outcomes (1)

• Exhaled breath condensate pH could predict ventilator associated pneumonia or death

  Follow up during mechanical ventilation (averaged less than 4 weeks)

Study Arms (1)

EBC pH

Observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Rosario: lead

Study Sites (1)

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 Province, 2152, Argentina

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Death

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis J Nannini, MD

  hospital E Perón. UNR. ARGENTINA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 13, 2011
• Study Start: August 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: August 4, 2011

Record last verified: 2008-05

Locations

AR (1)