Intubated ICU Patients

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02171091

Enrollment

Registered

2014-06-23

Start date

2016-12-01

Completion date

2017-08-08

Last updated

2018-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Requiring Endotracheal Intubation

Keywords

endotracheal, intubation, airway, inflammation

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results