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

Study Overview
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Brief Summary
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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.

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

Conditions
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Critically Ill

Intervention / Treatment
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* Device: T-line hemodynamic monitoring device (placement and use)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart rate and blood pressure determination<br>All subjects have the same conditions (T-line, blood pressure cuff, and radial artery catheter), in order to compare them within-subjects. | Device: T-line hemodynamic monitoring device (placement and use)<br>* 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.<br>* Other names: Hemodynamic monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressure |  | Assessed 24 times over four hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between the T-line and right heart catheter in determining cardiac output |  | Assessed every 30 minutes over four hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Heart rate, Cardiac output, Critical care, Perioperative care