Oxidative Lipidomic Biomarkers During Mechanical Ventilation in Critically Ill Patients (OXY-BAL).
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorOhio State University
About this trial
The aim of this study is to identify and determine the levels of oxidized lipids and lipid mediators following exposure to oxygen supplementation during mechanical ventilation by oxidative lipidomics. The investigators will include patients with mechanical ventilation and have received FiO2=\>0.5 atleast 90 minutes and collected two sequential mini bronchoalveolar lavage on them 24 hours apart. Mass Spectrometry Lipid chromatography will be conducted and clinical data will be analyzed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
1.Mechanical ventilation, only needed for performing procedures- bronchoscopy, esophagogastroduodenoscopy, colonoscopy, or others
2)Chronic respiratory failure prior to admission;
3)Hemoptysis or diffuse alveolar hemorrhage
4)Medication use such as N acetyl cysteine; aspirin, fish oil supplements.
Trial population
We will include all patients who are mechanically ventilated and age above \>=18 years. We will consent a patient if a bronchoalveolar lavage via fiber optic bronchoscopy (BAL) or through tracheal catheter (mini - BAL) is indicated for clinical care up to 72 hours since intubation and mechanical ventilation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
oxygen
Other interventionoxygen exposure of more than 50% for 1.5 hours
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Oxygen exposures1 intervention
Trial outcomes
Primary outcomes
1
Oxidized n6-PUFAs (Poly Unsaturated Fatty Acids)
Polyunsaturated fatty acids will be measured by mass spectrometry and compared in patients with optimized vs liberal oxygenation with moderated t tests
Time frame
days 1, and 22
Oxidized n3-PUFAs (Poly Unsaturated Fatty Acids)
Polyunsaturated fatty acids will be measured by mass spectrometry and compared in patients with optimized vs liberal oxygenation with moderated t tests
Time frame
days 1, and 2 of mechanical ventilationSecondary outcomes
1
Pro- inflammatory mediators-Prostaglandin E2, PGE2; 11-hydroxy--eicosatetraenoic acid 11-HETE, 5-hydroxy-eicosapentaenoic acid 5-HEPE
lipid mediators will be measured by mass spectrometry and compared in patients with optimized vs liberal oxygenation with moderated t tests
Time frame
days 1, and 2 of mechanical ventilation2
Correlation of oxidized lipid and lipid mediators to degree of oxygenation and oxygen delivery
AA, DGLA and lipid mediators levels in each category will be correlated to ventilator-free days using an analysis of covariance (ANCOVA) model. Other significant co variates will be assessed in multivariate logistic regression. Ventilator free days will be calculated
Time frame
From enrollment to liberation from mechanical ventilation or death whichever occurs earlier assessed upto 90 daysSponsors and contacts
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Source ClinicalTrials.gov