An observational study in Acute Hypercapnic Respiratory Failure, sponsored by Alung Technologies. Status unknown. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-01-28.
Sponsored by Alung Technologies · Observational
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.
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 99 is close to the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Alung Technologies is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Severe COPD or ARDS
Number of days in the ICU
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Number of days on Hemolung therapy
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Incidents
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Outcome at 28 days
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Patient mobility on Hemolung
Time frame: 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
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Arterial blood gas changes on Hemolung
Time frame: 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
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
CO2 removal and blood flow performance
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Hemolung-assisted weaning
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
No study locations are listed for this record.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Alung Technologies