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Clinical Trials/ISRCTN44583186
ISRCTN44583186
Completed
未知

BReath Analysis in intensive care: proof of concept for non-invasive diagnosis of Ventilator associated pneumonia

R&D University Hospital South Manchester0 sites120 target enrollmentJuly 2, 2015

Overview

Phase
未知
Intervention
Not specified
Conditions
Ventilator-associated pneumonia (VAP)
Sponsor
R&D University Hospital South Manchester
Enrollment
120
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Registry
who.int
Start Date
July 2, 2015
End Date
March 1, 2017
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
R&D University Hospital South Manchester

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria
  • 1\. 18 years and older
  • 2\. Intubated and mechanically ventilated for \>48 hours
  • 3\. Suspected for ventilator associated pneumonia (VAP)
  • Definition of suspected VAP
  • Criteria for clinically suspected VAP are fulfilled if a patient has been intubated and mechanically ventilated for at least 48 hours and has new or worsening alveolar infiltrates on chest X\-ray and has two or more from
  • 1\. Temperature \>38°C or \<35ºC
  • 2\. White cell count \>11x109 or \<4x109 per litre of blood
  • 3\. Purulent tracheal secretions

Exclusion Criteria

  • 1\. Patients receiving end of life care
  • 2\. Patients where there is clinical suspicion of highly infectious disease (patients in strict isolation such as Middle East Respiratory Syndrome, Ebola or resistant tuberculosis)
  • 3\. Patients showing features considered to predict poor tolerance of BAL:
  • 3\.1\. PaO2 \<8 kPa on FiO2 \>0\.7
  • 3\.2\. Positive end\-expiratory pressure \>15 cmH2O
  • 3\.3\. Peak airway pressure \>35 cmH2O
  • 3\.4\. Heart rate \>140 bpm
  • 3\.5\. Mean arterial pressure \<65 mmHg
  • 3\.6\. Bleeding diathesis (including platelet count \<20 x 109 p/L of blood or international normalised ratio (INR) \>3\)
  • 3\.7\. Poorly controlled intracranial pressure (\>20mmHg)

Outcomes

Primary Outcomes

Not specified

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