NCT01904305

Brief Summary

This study aims to determine whether interpretations of bronchoscopic results enable physicians to successfully predict the presence of pneumonia in traumatically injured patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
Last Updated

July 22, 2013

Status Verified

July 1, 2013

Enrollment Period

1.9 years

First QC Date

November 18, 2011

Last Update Submit

July 17, 2013

Conditions

Keywords

Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of hospital-acquired pneumonia

    When pneumonia is suspected, patient with undergo bronchoscopy. BAL specimens will be submitted to laboratory testing. Laboratory results are the definitive indication of pneumonia, or lack thereof.

    At first clinical suspicion of pneumonia. Average of hospital Day 4

Study Arms (1)

Patients receiving bronchoscopy

Patients suspected of having pneumonia received bronchoscopy to examine the lungs and to capture alveolar lavage culture

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Physicians working in the Surgical Intensive Care Unit

You may qualify if:

  • Critical Care staff and fellows of the Departments of Anesthesia and Surgery

You may not qualify if:

  • Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Cincinnati, Ohio, 45219, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Standard lavage specimens collected as part of standard of care and submitted for laboratory evaluation

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bryce RH Robinson, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

November 18, 2011

First Posted

July 22, 2013

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

July 22, 2013

Record last verified: 2013-07

Locations