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Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device

Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01311128
Enrollment
31
Registered
2011-03-09
Start date
2011-02-16
Completion date
2014-12-30
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill

Keywords

Blood pressure, Heart rate, Cardiac output, Critical care, Perioperative care

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.

Interventions

DEVICET-line hemodynamic monitoring device (placement and use)

The T-line device will be placed over the contralateral (from the radial artery catheter) radial artery at the distal wrist. To attach the device, a single-use sterile sensor is placed over the radial artery and the device then gently clamped around the wrist to incorporate the sensor. After a ten-minute stabilization period, data will be recorded every ten minutes during the first two hours of surgery, or until the patient is placed on cardiopulmonary bypass. The T-line device will then be removed. This procedure will be repeated, for a second two-hour period, in the ICU postoperatively.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frame
Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressureAssessed 24 times over four hours

Secondary

MeasureTime frame
Agreement between the T-line and right heart catheter in determining cardiac outputAssessed every 30 minutes over four hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026