Intubated ICU Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: Patients Requiring Endotracheal Intubation

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients receiving endotracheal intubation in the ICU

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

study arm; 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?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Carlos Puyo, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): August 4, 2017
• Study Completion (Actual): August 8, 2017

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: inflammation; intubation; airway; endotracheal
• Other Study ID Numbers: 201404106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No