The FDA has approved the CipherOx CRI T1 Tablet for use in subjects aged 19-36, and that this study aims to evaluate the device in subjects aged outside of this range and is being used off label. The FDA determined the Cipher OX CRI T1 Tablet to be a class II device in 2016, and additional research has been done since the FDA determination to further support the use of the device outside of its current labeling.
Study Type
OBSERVATIONAL
Enrollment
16
Monitoring via CRI
University of Colorado
Aurora, Colorado, United States
Volume of IV fluid infused
Volume of IV fluid infused during treatment
Time frame: 1 year
Quantity of Blood pressure medication administered
Amount of blood pressure medication utilized during treatment
Time frame: 1 year
Resuscitation status
Categorical determination of resuscitation status as over- or under- resuscitated
Time frame: 1 year
FiO2 needs
FiO2 levels administered
Time frame: 1 year
Days on Oxygen
Days spent on oxygen
Time frame: 1 year
Number of participants with hospital acquired pneumonia
Number of participants with hospital acquired pneumonia
Time frame: 1 year
Number of Patients with Acute Kidney Injury (AKI)
Number of patients who acquire an acute kidney injury
Time frame: 1 year
Number of patients with hemodynamic collapse
Number of patients who experience hemodynamic collapse defined as drop in systolic blood pressure below 80mm Hg
Time frame: 1 year
mortality
Number of patients who experience mortality
Time frame: 1 year
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