Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT05412810

Conditions

Mechanical Ventilation Complication

Hyperoxia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

oxygen

Study Details

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

Study ID

NCT05412810

Start date

Mar 1, 2023

Status verified date

Apr, 2024

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  • 5)Primary team prohibits bronchoscopy for a specific clinical indication or safety;

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Oxygen exposures

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

Interventions

oxygen

oxygen exposure of more than 50% for 1.5 hours

Primary outcome measure

  • Oxidized n6-PUFAs (Poly Unsaturated Fatty Acids) [ Time Frame: days 1, and 2 ]
  • Oxidized n3-PUFAs (Poly Unsaturated Fatty Acids) [ Time Frame: days 1, and 2 of mechanical ventilation ]

Central Contacts and Locations

Central contacts

Sarah Karow

6142920031sarah.karow@osumc.edu

Locations

Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Sonal Pannu

507-226-1636sonal.pannu@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Apr 26, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2024-04-26.