Hemolung RAS Registry Program

Study Overview
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Brief Summary
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The purpose of the Hemolung RAS Registry Program is to collect retrospective, de-identified, standard of care data following the commercial use of the Hemolung RAS.

Detailed Description
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ALung's post-market Hemolung RAS Registry Program provides a continuum for measuring the Hemolung RAS effectiveness and safety in a real-world setting beyond the results reported in pre-market clinical feasibility studies. The Hemolung RAS Registry Program is part of ALung's 1) evaluation of clinical evidence throughout the life cycle of the product, 2) longer term residual risk assessment of the product, and 3) commitment to maintain quality systems and integrate continuous quality improvements in the product. On a voluntary basis, participating physicians and institutional staff enter de-identified data online in the secure, password protected, regulatory-compliant Hemolung RAS Registry Portal in a retrospective manner following a patient's ICU discharge, status at 28 days post-Hemolung therapy, or death whichever is earlier. There is no requirement to collect and report data outside of standard of care. The program's methodology, data monitoring and statistical analysis plan is consistent with this type of initiative in a real-world setting.

Official Title
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HL-CA-1600, Hemolung RAS Registry. A Retrospective Registry Involving Voluntary Reporting of De-identified, Standard of Care Data Following the Commercial Use of the Hemolung Respiratory Assist System (RAS)

Conditions
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Acute Hypercapnic Respiratory Failure

Participation Criteria
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Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days in the ICU |  | Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation. | 
| Number of days on Hemolung therapy |  | Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation. | 
| Incidents |  | Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation. | 
| Outcome at 28 days |  | Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient mobility on Hemolung |  | Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation. | 
| Blood product usage and hematologic effects on Hemolung |  | Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation. | 
| Arterial blood gas changes on Hemolung |  | Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation. | 
| Ventilatory mode and setting changes on Hemolung |  | Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation. | 
| CO2 removal and blood flow performance |  | Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation. | 
| Hemolung-assisted weaning |  | Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation. |