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

NCT ID: NCT01311128

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-16
• Study Completion Date: 2014-12-30

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.

Conditions

Critically Ill

Study Groups

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.

T-line hemodynamic monitoring device (placement and use)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

T-line; Tensymeter; Tensys Medical, Inc.; Hemodynamic monitoring

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Phillips, MD

Role: PRINCIPAL_INVESTIGATOR

503-494-2465

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

6980

Identifier Type: -

Identifier Source: org_study_id