NCT01311128

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-02-16
• Primary completion: 2012-06-29
• Completion: 2014-12-30
• First posted: 2011-03-09
• Last updated: 2019-08-28

Locations

1 site across 1 country: United States