NCT02652247

Brief Summary

To determine if the analysis of exhaled breath condensate correlates with the development \& resolution of pneumonia.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

6.4 years

First QC Date

January 7, 2016

Last Update Submit

August 1, 2022

Conditions

Ventilator Associated Pneumonia (VAP)

Keywords

traumaventilatorsurgical ICU

Outcome Measures

Primary Outcomes (2)

  • The number of patients with a positive association between the exhaled breath condensate fluid and BAL fluid in in patients suspected of pneumonia.

    To determine the association between the microbial community in both EBCF specimens and bronchoalveolar lavage fluid (BALF) samples in critically ill and injured, mechanically ventilated patients suspected of VAP.

    enrollment to hospital day 15

  • The per cent of positive correlation for the development & resolution of pneumonia based on changes in bacteria found in the exhaled breath condensate.

    To develop a robust predictive model for the development of VAP and its resolution based on changes in the microbial community in EBCF collected over the course of ventilation.

    enrollment to hospital day 15

Study Arms (4)

ventilated trauma patients with pneumonia

EXPERIMENTAL

ventilated trauma patients with pneumonia

Procedure: molecular analysis of exhaled breath condensateProcedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirateProcedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate

ventilated trauma patients without pneumonia

EXPERIMENTAL

ventilated trauma patients without pneumonia

Procedure: molecular analysis of exhaled breath condensateProcedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate

ventilated surgical ICU patients with pneumonia

EXPERIMENTAL

ventilated surgical ICU patients with pneumonia

Procedure: molecular analysis of exhaled breath condensateProcedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirateProcedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate

ventilated surgical ICU patients without pneumonia

EXPERIMENTAL

ventilated surgical ICU patients without pneumonia

Procedure: molecular analysis of exhaled breath condensateProcedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate

Interventions

molecular analysis of exhaled breath condensatePROCEDURE
ventilated surgical ICU patients with pneumoniaventilated surgical ICU patients without pneumoniaventilated trauma patients with pneumoniaventilated trauma patients without pneumonia
molecular analysis of mini-bronchoalveolar lavage (BAL) aspiratePROCEDURE
ventilated surgical ICU patients with pneumoniaventilated surgical ICU patients without pneumoniaventilated trauma patients with pneumoniaventilated trauma patients without pneumonia
molecular analysis of bronchoalveolar lavage (BAL) aspiratePROCEDURE
ventilated surgical ICU patients with pneumoniaventilated trauma patients with pneumonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Admitted to the Vanderbilt Trauma (TICU) and Surgical Intensive Care Units (SICU)
  • Mechanically ventilated for ≥2 successive days (without planned extubation within 24 hours of enrollment)

You may not qualify if:

  • Less than 18 years of age
  • Expected survival less than 24 hours
  • Anticipated extubation within 24 hours of enrollment
  • Conditions limiting the subject's ability to tolerate collection of lavage specimens, including: FIO2 \> 80%; PEEP \> 16 cmH2O; Intracranial pressure \>20 cmH2O; Tracheal or mucosal bleeding; Platelet count \< 20,000 cells/uL; INR \> 2.0
  • Known prisoners
  • Pneumonia diagnosis at the time of ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedWounds and Injuries

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Addison K May, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 11, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)