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

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 Overview

• Status: Terminated
• Conditions: Critically Ill
• Intervention / Treatment: Device: T-line hemodynamic monitoring device (placement and use)

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Heart rate and blood pressure determination; 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); 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.; Other Names: T-line; Tensymeter; Tensys Medical, Inc.; Hemodynamic monitoring

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Charles Phillips, MD, 503-494-2465

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2011
• Primary Completion (Actual): June 29, 2012
• Study Completion (Actual): December 30, 2014

Study Registration Dates

• First Submitted: March 8, 2011
• First Submitted That Met QC Criteria: March 8, 2011
• First Posted (Estimate): March 9, 2011

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 23, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Perioperative care; Cardiac output; Critical care; Blood pressure; Heart rate
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 6980 (CTEP)