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Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck
NCT02488174 · View on ClinicalTrials.gov ↗
Study Summary
Severe acute respiratory failure (ARF) requiring prolonged mechanical ventilation is the most common form of acute organ dysfunction in the hospital, and is often associated with multiple organ failure (MOF), high mortality, and functional impairment. Most studies on ARF have focused on patients in the intensive care unit (ICU) after they have been on mechanical ventilation for days and end organ damage is already established. The overall goal of this proposed project is to improve the outcomes of patients at high risk for developing severe ARF and prolonged mechanical ventilation in and outside of the ICU. The project aims to intervene early in high risk patients with an electronic medical records (EMR)-based, patient-centered checklist of common critical care practices aimed at preventing lung injury and hospital acquired adverse events that commonly lead to organ failure (Prevention of Organ Failure checklist -PROOFcheck). This application proposes a stepped-wedge, clustered randomized control trial to determine the utility of PROOFcheck to improve survival and reduce the duration of mechanical ventilation and multiple organ failure in patients identified as high risk for progressing to severe ARF and prolonged mechanical ventilation. The aims in the UH2 phase are: 1) to refine a previously validated Lung Injury Prediction Score into a pragmatic, EMR-based early prediction model to Accurately Predict Prolonged Ventilation (APPROVE), which will automatically identify patients anywhere in the hospital who are at high risk for developing severe ARF requiring mechanical ventilation \>48 hours; 2) to incorporate PROOFcheck into the EMR to prompt clinicians on care practices to limit lung injury, prevent adverse events, and avoid additional organ failure; and 3) to establish the infrastructure for the proposed trial. The proposed pragmatic trial will harness the hospital-wide EMR to identify patients at high risk for prolonged mechanical ventilation with APPROVE for in
Conditions Studied
Interventions
- OTHER Standard Care
- OTHER PROOFcheck
Study Locations (3)
Florida
- Mayo Clinic — Jacksonville
Minnesota
- Mayo Clinic — Rochester
New York
- Montefiore Medical Center — The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34,040 participants |
| Start Date | 2015-08 |
| Est. Completion | 2018-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02488174
The ClinicalTrials.gov registry entry for NCT02488174 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34,040 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Respiratory Failure appearing as the primary indexed condition, and to 2 interventions — of which Standard Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02488174 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Florida, Minnesota, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02488174 about?
NCT02488174 is a clinical study titled "Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck". Severe acute respiratory failure (ARF) requiring prolonged mechanical ventilation is the most common form of acute organ dysfunction in the hospital, and is often associated with multiple organ failure (MOF), high mortality, and functional impairment. Most studies on ARF have focused on patients in ...
What is the current status of trial NCT02488174?
This trial is currently completed. It is a NA study. The enrollment target is 34,040 participants. The study started on 2015-08. Estimated completion is 2018-09.
What conditions does trial NCT02488174 study?
This clinical trial studies the following conditions: Respiratory Failure, Multiple Organ Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02488174?
The interventions under investigation include: Standard Care (OTHER), PROOFcheck (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02488174?
This trial is sponsored by Albert Einstein College of Medicine, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02488174 being conducted?
This trial has 3 study locations across Florida, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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