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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by Oregon Health and Science University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT01311128

First received: March 8, 2011

Last updated: May 27, 2011

Last verified: March 2011

History of Changes

Purpose

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	Intervention
Critically Ill	Device: T-line hemodynamic monitoring device (placement and use)

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Agreement between the T-line and right heart catheter in determining cardiac output [ Time Frame: Assessed every 30 minutes over four hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	March 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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. Other Names: T-line Tensymeter Tensys Medical, Inc. Hemodynamic monitoring

Arms

Assigned Interventions

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.

Other Names:

T-line
Tensymeter
Tensys Medical, Inc.
Hemodynamic monitoring

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311128

Contacts

Contact: Samantha S Ruimy, MSIS	(503) 494-0724	ruimy@ohsu.edu
Contact: Charles Phillips, MD	(503) 494-2465	phillipc@ohsu.edu

Locations

United States, Oregon
Oregon Health & Science University	Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Charles R Phillips, MD

Sponsors and Collaborators

Oregon Health and Science University

More Information

No publications provided

Responsible Party:	Charles Phillips, MD, Oregon Health & Science University
ClinicalTrials.gov Identifier:	NCT01311128 History of Changes
Other Study ID Numbers:	6980
Study First Received:	March 8, 2011
Last Updated:	May 27, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Blood pressure
Heart rate
Cardiac output
Critical care
Perioperative care

Additional relevant MeSH terms:

Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013

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