Breath analysis in intensive care

Not Applicable

Completed

• Conditions: Ventilator-associated pneumonia (VAP); Respiratory

• Registration Number: ISRCTN44583186
• Lead Sponsor: R&D University Hospital South Manchester

Brief Summary

2016 thesis in https://search.proquest.com/openview/dfec1c5fbbc8034f4a934811757218a8/1?pq-origsite=gscholar&cbl=2026366&diss=y (added 23/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-02
• Study Completion: 2017-03-01
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Providing proof of concept supporting the use of a novel minimally-invasive breath sampler to enhance the diagnosis of ventilator-associated pneumonia (VAP) in patients in intensive care.

Secondary Outcome Measures

Name	Time	Method
<br> 1. The development of a bespoke minimally-invasive breath sampling methodology for critically ill ventilated patients on a mechanical ventilator<br> 2. Precise identification of the breath biomarkers / VOCs responsible for discriminating VAP in critical ill patients<br>