Clinician Ability to Predict the Presence of Nosocomial P... | NCT01904305

Studies
Clinician Ability to Predict the Presence of Nosocomial Pneumonia Based on Bronchoscopic Findings

NCT01904305

Sponsor

University of Cincinnati

Status

Completed

Last Update Posted

Jul 22, 2013Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Pneumonia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Feb 2013Actual

First Submitted Date

Nov 18, 2011

First Submission Date that Met QC Criteria

Jul 17, 2013

First Posted Date

Jul 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2013

Last Update Posted Date

Jul 22, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bryce Robinson, MD, Assistant Clinical Professor, University of CincinnatiPrincipal Investigator

Lead Sponsor

University of CincinnatiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study aims to determine whether interpretations of bronchoscopic results enable physicians to successfully predict the presence of pneumonia in traumatically injured patients. Bronchoscopies will be videotaped. The clinician doing the procedure will make prediction as to whether the patient, in fact, has pneumonia. In addition, at least one other physician will view the videotape and predict whether the patient has pneumonia.

Once laboratory results are available, the physician predictions will be compared against the definitive laboratory determination

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients receiving bronchoscopy		Patients suspected of having pneumonia received bronchoscopy to examine the lungs and to capture alveolar lavage culture

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Refusal of consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Physicians working in the Surgical Intensive Care Unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bryce RH Robinson, MD	University of Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Cincinnati	Ohio	45219	United States

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided