Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device
|ClinicalTrials.gov Identifier: NCT01311128|
Recruitment Status : Unknown
Verified March 2011 by Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : March 9, 2011
Last Update Posted : May 30, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Critically Ill||Device: T-line hemodynamic monitoring device (placement and use)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||September 2011|
Experimental: 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 intervention will be repeated, for a second two-hour period, in the ICU postoperatively.
- Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressure [ Time Frame: Assessed 24 times over four hours ]
- Agreement between the T-line and right heart catheter in determining cardiac output [ Time Frame: Assessed every 30 minutes over four hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311128
|Contact: Samantha S Ruimy, MSIS||(503) firstname.lastname@example.org|
|Contact: Charles Phillips, MD||(503) email@example.com|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Principal Investigator: Charles R Phillips, MD|