Intubated ICU Patients

ID: NCT02171091
Status: Recruiting
Phase: N/A
Start Date: June 01, 2014
First Submitted: June 19, 2014
Last Updated: February 08, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Patients Requiring Endotracheal Intubation
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

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

Condition or disease Intervention/treatment Phase

Patients Requiring Endotracheal Intubation

N/A

Tracking Information

First Submitted DateJune 19, 2014
Last Update Posted DateFebruary 08, 2018
Start DateJune 01, 2014
Anticipated Completion DateJune 01, 2019
Primary Completion DateDecember 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Neutrophil changes [Time Frame: 72 hours]

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • analyze neutrophil activation [Time Frame: 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 [Time Frame: 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 [Time Frame: 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleIntubated ICU Patients
Official TitleImpact of the Endotracheal Tube on Airway Inflammation: Prospective Analysis in Intubated ICU Patients
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

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
225
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Patients Requiring Endotracheal Intubation
Target Follow-Up Duration N/A
Biospecimen:
Retention: Samples With DNA
Description: blood and tracheal sample
Sampling MethodNon-Probability Sample
Study Populationpatients receiving endotracheal intubation in the ICU
Intervention
Not Available
Study Groups/Cohorts
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.

Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Recruiting
Enrollment225
Completion DateJune 01, 2019
Eligibility Criteria: 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
GenderAll
Age18 Years to 85 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02171091
Other Study ID Numbers
201404106
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Carlos Puyo, MD
Washington University School of Medicine