Intubated ICU Patients

Study Overview
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Brief Summary
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The purpose of this research study is to determine how cell changes during endotracheal intubation and artificial lung ventilation affect lung inflammation. Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal (windpipe) lavage will be obtained each day for up to 72 hours. Lung samples or fiberoptic (lung) samples will be collected at the same time intervals when possible and if they are done as standard of care. Blood samples will be obtained simultaneous with the collection of the trachael (windpipe) specimens.

Official Title
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Impact of the Endotracheal Tube on Airway Inflammation: Prospective Analysis in Intubated ICU Patients

Conditions
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Patients Requiring Endotracheal Intubation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Ages 18 to 85 Required to have endotracheal intubation Admitted to an intensive care unit Exclusion Criteria On immunosuppressive medications Previous tracheal surgery On azithromycin Pregnancy Cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study arm<br>One tracheal sample will be obtained using sterile (5 ml) sterile saline solution using irrigation and wall suction from each patient every day for 72 hours, total sampling time is approximately 10 seconds per specimen. Lung samples or fiberoptic obtained samples will be collected at same time intervals as the tracheal samples when possible and if they are done as standard of care. Samples will not be collected for research only and the time for this procedure will not be extended to collect extra tissue. A blood sample (10ml) will be collected simultaneously with the airway samples and also will be used for baseline control measurements. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophil changes | Identifying indicators of neutrophil inflammatory changes that occur during 72 hours of tracheal injury secondary to endotracheal intubation. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analyze neutrophil activation | Analyze neutrophil activation in the distal airways in biological samples obtained simultaneously with tracheal samples and to correlate them with the development of lung inflammation. | 72 hours | 
| correlate tracheal and lung neutrophil activation | Correlate tracheal and lung neutrophil activation with development of pneumonia in ICU patients requiring mechanical ventilation. | 72 hours | 
| determine the impact of airway (tracheal, lung) inflammation | Determine the impact of airway (tracheal, lung) inflammation as determined by neutrophil activation on the length of stay (LOS), discharge, and readmission to ICU in the first 90 days post airway inflammation (VAP) diagnosis. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endotracheal, intubation, airway, inflammation