Intubated ICU Patients

Terminated

• Conditions: Patients Requiring Endotracheal Intubation

• Registration Number: NCT02171091
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-23
• Study Start: 2016-12-01
• Primary Completion: 2017-08-04
• Study Completion: 2017-08-08
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-13
• Last Update Posted: 2018-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neutrophil changes	72 hours	Identifying indicators of neutrophil inflammatory changes that occur during 72 hours of tracheal injury secondary to endotracheal intubation.

Secondary Outcome Measures

Name	Time	Method
analyze neutrophil activation	72 hours	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.
correlate tracheal and lung neutrophil activation	72 hours	Correlate tracheal and lung neutrophil activation with development of pneumonia in ICU patients requiring mechanical ventilation.
determine the impact of airway (tracheal, lung) inflammation	72 hours	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States