Oxidative Lipidomic Biomarkers During Mechanical Ventilation in Critically Ill Patients (OXY-BAL).

NCT05412810 | Recruiting

• 1 other identifier: 2018H0302
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation Complication; Hyperoxia

Outcome Measures

Primary Outcomes (2)

• 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

  days 1, and 2

• 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

  days 1, and 2 of mechanical ventilation

Secondary Outcomes (2)

• Pro- inflammatory mediators-Prostaglandin E2, PGE2; 11-hydroxy--eicosatetraenoic acid 11-HETE, 5-hydroxy-eicosapentaenoic acid 5-HEPE

  days 1, and 2 of mechanical ventilation

• Correlation of oxidized lipid and lipid mediators to degree of oxygenation and oxygen delivery

  From enrollment to liberation from mechanical ventilation or death whichever occurs earlier assessed upto 90 days

Study Arms (1)

Oxygen exposures

mechanically ventilated patients with atleast 1.5 hours of FiO2 exposure of 50% or more

Other: oxygen

Interventions

oxygen OTHER

oxygen exposure of more than 50% for 1.5 hours

Oxygen exposures

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Adults age =\> 18 and needing Mechanical ventilation in Intensive Care unit expected atleast for 48 hours

You may not qualify if:

• Mechanical ventilation, only needed for performing procedures- bronchoscopy, esophagogastroduodenoscopy, colonoscopy, or others
• )Chronic respiratory failure prior to admission;
• )Hemoptysis or diffuse alveolar hemorrhage
• )Medication use such as N acetyl cysteine; aspirin, fish oil supplements.
• )Primary team prohibits bronchoscopy for a specific clinical indication or safety;

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

All consenting patients will have an additional 5 ml bronchoalveolar fluid collected during the procedure. Additionally, 5 cc blood will also be collected to correlate with the BAL samples.

MeSH Terms

Conditions

Hyperoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Central Study Contacts

Sarah Karow

CONTACT

6142920031; sarah.karow@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: June 9, 2022
• Study Start: March 1, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

US (1)