|- candidate number||9099|
|- NTR Number||NTR2749|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-feb-2011|
|- Secondary IDs||10/262 MEC AMC|
|- Public Title||BREathprint Variation during Intubation, mechanical ventilation and Anesthesia.|
|- Scientific Title||BREathprint Variation during Intubation, mechanical ventilation and Anesthesia. |
|- hypothesis||1. Breathprints, generated by an electronic nose, variate during mechanical ventilation;|
2. Breathprints correlate with biological markers for oxidative stress and lung injury during mechanical ventilation.
|- Healt Condition(s) or Problem(s) studied||Ventilator associated lung injury|
|- Inclusion criteria||1. Planned elective surgery (with planned intubation >5h);|
2. Informed consent;
3. Anesthesia with intravenous anesthestics.
|- Exclusion criteria||1. < 18 years of age;|
2. History of any chronic or acute pulmonary condition (asthma, COPD, CF, pulmonary malignancy or acute lung injury);
3. Intubation and mechanical ventilation within the last 7 days.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2011|
|- planned closingdate||1-jan-2012|
|- Target number of participants||25|
|- Primary outcome||1. Breathprint (exhaled biomarkers) as obtained by electronic nose measurement (Cyranose and ContiNose);|
2. Systemic biological markers of oxidative stress and lung injury (e.g. Urin acid, IL-1b, IL-6, IL-8, TNFa en MPO).
|- Secondary outcome||N/A|
|- Timepoints||Both exhaled as systemic biomarkers are collected before, during and after operation. During operation breathprints are continuously obtained by ContiNose and are measured once an hour by Cyranose. Blood is collected every hour. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Lieuwe D.J. Bos|
|- CONTACT for SCIENTIFIC QUERIES|| Lieuwe D.J. Bos|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Exhaled human breath contains thousands of volatile organic compounds (VOCs) in gas phase. Electronic noses (eNoses) produce breathprints based on VOCs using an array of different sensors. Subsequently, these breathprints can be analyzed and used for diagnostic purposes.
It is uncertain whether intubation and mechanical ventilation per se influence breathprints.
The goal of the present investigation is to determine breathprint variation in intubated and mechanically ventilated patients without pre–existing lung injury before, during and after short–term intubation and mechanical ventilation.
Prospective observational study.
Twenty–five patients without preexisting lung injury, who need short–term intubation and mechanical ventilation. For this we choose to include patients scheduled for elective surgery.
Main study endpoints:
1. Breathprint (exhaled biomarkers) as obtained by electronic nose measurement (Cyranose and ContiNose);
2. Systemic biological markers of oxidative stress and lung injury.
1. Principal component analysis to extract discriminative features from the large-dimensional dataset;
2. Independent samples t-test for difference in breathprints between before intubation and after mechanical ventilation;
3. Pearson’s Correlation coefficient for correlations between breathprints and oxygenation parameters, systemic biological markers.
|- Main changes (audit trail)|
|- RECORD||11-feb-2011 - 22-feb-2011|