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Study to Determine Quicker Methods of Diagnosing Pneumonia Caused by a Breathing Machine in Critically Ill Patients

NCT ID: NCT00938002

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2019-09-19

Brief Summary

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Critically ill patients on a breathing machine are at risk of developing a type of pneumonia called Ventilator Acquired Pneumonia (VAP). The purpose of this study is to determine if regular lung rinses sent for microbiological testing can reduce the time to diagnose VAP. The study also plans to test the accuracy and speed of a new technology, using multiplexed automated digital microscopy, to identify the germs causing the VAP.

Detailed Description

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Ventilator-associated pneumonia (VAP) is a common, life-threatening hospital-acquired infectious complication of prolonged mechanical ventilation (MV). Despite aggressive efforts to prevent VAP, rates remain high because clinical diagnosis is imprecise and microbiological diagnosis is frequently delayed. Diagnosis of VAP depends on clinical signs as well as microbiologic evidence from Bronchioalveolar Lavage (BAL) cultures. Ordinarily, these cultures are only ordered after the patient presents with clinical signs and symptoms of VAP, which can significantly delay diagnosis and effective therapy. This research proposes to implement additional surveillance BAL cultures in order to reduce the time to diagnosis of VAP in mechanically ventilated critically ill adults. To further reduce the time to diagnosis of VAP, this research aims to test part of the BAL cultures using a novel flowcell/surface-capture device that allows direct from specimen visualization of bacteria using multiplexed automated digital microscopy (BACcelâ„¢) for rapid bacterial identification and antibiotic resistance testing. Additionally, molecular assays of the BAL sample will characterize lower respiratory tract antimicrobial peptide host-innate immune molecule and local anti-oxidant defenses in mechanically ventilated adults at risk for VAP.

Conditions

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Ventilator Acquired Pneumonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Acceler8 Pheno

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Written, informed consent (by surrogate if unconscious or if altered mental status)
2. ≥ 18 years old
3. Admission to a Medical Intensive care unit
4. Orally/nasally intubated, evaluable within 72 h of initial intubation
5. Expected to remain mechanically ventilated for at least 48 h after the first study procedure

Exclusion Criteria

1. Previously documented cystic fibrosis
2. Diffuse bronchiectasis
3. Severe or massive hemoptysis
4. Presence of an advanced directive to withhold life-sustaining treatment
5. Morbid state or expected to survive less than 14 days because of an advanced co-morbid medical condition
6. Participation in a clinical trial of any unlicensed drug or device within 30 days
7. Pregnant or Nursing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Accerl8 Technology Corporation

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role lead

Responsible Party

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Ivor Douglas

Chief, Pulmonary Sciences & Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivor S Douglas, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health and Hospital Authority

Connie S Price, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health and Hospital Authority

Locations

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Denver Health Medical Center

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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UL1RR025780

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-0321

Identifier Type: -

Identifier Source: org_study_id