NCT01311128TerminatedNot Applicable
Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device
Oregon Health and Science University1 site in 1 country31 target enrollmentStarted: February 16, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressure
Study Overview
Brief Summary
This protocol will test a new non-invasive device, the T-line, in continuously determining heart rate and blood pressure in operative and critically ill patients. The accuracy of the device will be compared to the standard radial artery catheter, as well as to the non-invasive blood pressure cuff. The T-line will also be compared to the right heart catheter determining cardiac output in at least 20 patients.
Hypothesis: the T-line device will determine blood pressure and heart rate as accurately as a standard radial arterial catheter and a blood pressure cuff in perioperative patients.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age at least 18 years old
- •Operative patients expected to require intensive care recovery at OHSU
- •Planned or existing intra- and postoperative radial artery catheterization as part of routine care
- •Palpable contralateral (to catheter) radial artery pulse
- •Planned intraoperative right heart catheter placement as part of routine clinical care, in at least 20 subjects of total
Exclusion Criteria
- •No palpable radial artery pulse
- •Anatomical abnormalities (skin grafts, cysts, cellulitis) or injuries (scarring, cuts, burns, bruising) at the sensor site
- •An intravenous line placed at the sensor application site or within the medial/lateral travel range of the sensor
- •An AV shunt in the T-line arm
- •Known sensitivity to pressure stimuli (dermatographism)
Outcomes
Primary Outcomes
Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressure
Time Frame: Assessed 24 times over four hours
Secondary Outcomes
- Agreement between the T-line and right heart catheter in determining cardiac output(Assessed every 30 minutes over four hours)
Investigators
Study Sites (1)
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