Automated Non-Invasive Blood Pressure Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGE Healthcare
About this trial
The purpose of the study is to design and implement methods to make an algorithm to estimate blood pressure changes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to provide written informed consent or have a LDR to provide written informed consent;
Are being cared for in OR, PACU or ICU and are expected to remain in the unit for the duration of the study procedure;
Have an invasive blood pressure measurement as a standard of care; AND
Are 18 years of age or older.
Disqualifiers
Are known to be pregnant;
Are breastfeeding;
Are suffering from infection(s) that require isolation; OR
Have an external heart assistant device.
Trial population
Patients treated in Meilahti hospital
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Primary Outcome Measure
The primary outcome is to collect SpO2 data using Automated Non-Invasive Blood Pressure from subjects in ICU, OR and PACU environment using the investigational system. This data will be used for engineering development purposes.
Time frame
Up to 24 hours after time of enrollmentOther outcomes
1
Safety Outcome
The safety outcome of this study are type and number of AEs, SAEs, and device deficiencies.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov