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

Rapid Bacterial Identification and Antibiotic Resistance Testing in Critically Ill Adults at Risk for Ventilator Acquired Pneumonia (VAP).

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Acquired Pneumonia
• Intervention / Treatment: Diagnostic test: Acceler8 Pheno

Detailed Description

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 (BACcel™) 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.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill ventilated patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in time to diagnosis and treatment of VAP in an at risk population	30 days

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: National Center for Research Resources (NCRR); Accerl8 Technology Corporation
• Investigators: Principal Investigator: Ivor S Douglas, MD, Denver Health and Hospital Authority; Principal Investigator: Connie S Price, MD, Denver Health and Hospital Authority

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): September 19, 2019
• Study Completion (Actual): September 19, 2019

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 22, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 09-0321; UL1RR025780 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No