Intubated ICU Patients

Patients Requiring Endotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02171091
• Other study ID #: 201404106
• Status: Terminated
• Start date: December 1, 2016
• Est. completion date: August 8, 2017

Study information

• Verified date: November 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 8, 2017
• Est. primary completion date: August 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria

1. Ages 18 to 85

2. Required to have endotracheal intubation

3. Admitted to an intensive care unit

Exclusion Criteria

1. On immunosuppressive medications

2. Previous tracheal surgery

3. On azithromycin

4. Pregnancy

5. Cancer

Related Conditions & MeSH terms

• Patients Requiring Endotracheal Intubation

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutrophil changes	Identifying indicators of neutrophil inflammatory changes that occur during 72 hours of tracheal injury secondary to endotracheal intubation.	72 hours
Secondary	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
Secondary	correlate tracheal and lung neutrophil activation	Correlate tracheal and lung neutrophil activation with development of pneumonia in ICU patients requiring mechanical ventilation.	72 hours
Secondary	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